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Last reviewed against primary sources: June 12, 2026
Do You Qualify?
Eligibility Checklist
- Underwent an ERCP procedure at a hospital or surgical center
- Procedure was performed using an Olympus TJF-series duodenoscope (TJF-Q180V, TJF-Q190V, TJF-Q290V, or TJF-Q170V)
- Developed a CRE infection or other serious bacterial infection within days or weeks after the procedure
- Required hospitalization, extended antibiotic treatment, ICU care, or surgical intervention for the infection
- Can document the procedure and infection through medical records and culture results
- Family member of a patient who died from a post-ERCP infection involving an Olympus duodenoscope (wrongful death claim)
- Injury occurred within the applicable statute of limitations (discovery rule may apply)
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How Olympus TJF-Q180V Duodenoscopes Cause Superbug Infections
In Plain Language
The Olympus TJF-Q180V duodenoscope, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat bile duct and pancreatic conditions, has been linked to outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and other multidrug-resistant organisms. The device's complex elevator mechanism — a small wire-controlled lever at the instrument's distal tip — creates microscopic crevices that trap biological material and harbor bacteria even after the manufacturer's recommended reprocessing (high-level disinfection) protocols are followed. Patients undergoing ERCP with contaminated duodenoscopes are exposed to life-threatening infections that resist last-resort antibiotics.
Elevator Mechanism Bacterial Entrapment
The TJF-Q180V's distal tip contains a small elevator mechanism used to guide catheters and wires into the bile duct during ERCP. This elevator sits within a sealed channel with microscopic gaps between the elevator lever, its housing, and the surrounding O-ring seals. During procedures, patient fluids — bile, blood, and tissue debris — are forced into these crevices under hydraulic pressure. The gaps are too narrow for cleaning brushes to reach and too complex for chemical disinfectants to fully penetrate, creating a persistent bacterial reservoir that transfers organisms from patient to patient.
Reprocessing Protocol Failure
Olympus's FDA-cleared reprocessing instructions required manual brushing followed by automated high-level disinfection (HLD). However, the elevator channel's geometry makes complete manual cleaning physically impossible — studies have demonstrated that even meticulous adherence to Olympus's protocol leaves residual biological material and viable bacteria in the elevator mechanism. The FDA found that Olympus's reprocessing instructions were never clinically validated to achieve sterilization of the elevator channel, meaning the manufacturer marketed a device with cleaning instructions it knew or should have known were inadequate.
CRE and Multidrug-Resistant Organism Transmission
Carbapenem-resistant Enterobacteriaceae (CRE) — sometimes called 'nightmare bacteria' by the CDC — are gram-negative organisms resistant to carbapenems, the antibiotics of last resort. When CRE colonize a duodenoscope's elevator mechanism, subsequent patients undergoing ERCP with that instrument can have the organisms directly introduced into their bile duct, an anatomically privileged site with limited immune surveillance. CRE bloodstream infections carry mortality rates of 40-50%, and treatment options are extremely limited.
Biofilm Formation in Device Channels
Once bacteria colonize the elevator mechanism's crevices, they form biofilms — structured communities of microorganisms encased in a protective extracellular matrix. Biofilms are orders of magnitude more resistant to chemical disinfection than free-floating bacteria. Once established in a duodenoscope, biofilms can persist through hundreds of reprocessing cycles, continuously seeding new infections. Standard high-level disinfection protocols were not designed to eliminate established biofilms in complex medical device channels.
Scope-to-Patient Cross-Contamination Chain
The transmission chain is direct and traceable: contaminated duodenoscope is used on Patient A, reprocessed according to manufacturer instructions, then used on Patient B who develops CRE infection with the same bacterial strain (confirmed by whole-genome sequencing). CDC and hospital epidemiology investigations at UCLA, Virginia Mason, and other facilities established definitive scope-to-patient transmission chains, ruling out other infection sources and confirming the duodenoscope as the vector.
Danger Factors
- Sealed Elevator Design Defect: The TJF-Q180V's elevator mechanism was designed with a sealed distal tip that prevented visual inspection and effective mechanical cleaning of internal crevices — a fundamental design choice that prioritized device longevity over patient safety and created an inherent infection risk that no reprocessing protocol could fully mitigate.
- Inadequate and Unvalidated Reprocessing Instructions: Olympus provided reprocessing instructions that were never clinically validated to achieve sterilization of the elevator channel. The FDA later determined that the instructions were insufficient, but Olympus continued marketing the device with the same cleaning protocol for years after outbreaks were reported.
- CRE Lethality and Antibiotic Resistance: The organisms transmitted by contaminated duodenoscopes — particularly CRE — carry mortality rates of 40-50% for bloodstream infections and are resistant to nearly all available antibiotics. Patients who survive CRE infections often face prolonged hospitalization, organ damage, and permanent health consequences.
- Olympus Market Dominance Limiting Alternatives: Olympus controlled approximately 85% of the global duodenoscope market, meaning hospitals had few viable alternatives even after infection risks were documented. This market dominance meant contaminated devices remained in clinical use at thousands of facilities while Olympus resisted design changes.
- Delayed Disclosure of Known Risks: Internal Olympus documents and regulatory correspondence indicate the company was aware of duodenoscope-linked infection reports in Europe years before U.S. outbreaks became public. Olympus did not proactively warn U.S. hospitals or the FDA, delaying corrective action that could have prevented infections and deaths.
- Vulnerable Patient Population: ERCP procedures are performed on patients with serious hepatobiliary and pancreatic conditions — many of whom are already immunocompromised, elderly, or critically ill. These patients are least able to withstand CRE superinfection, amplifying the consequences of device contamination.
Scientific Consensus
- The elevator mechanism design of the TJF-Q180V creates crevices that cannot be adequately cleaned by manual or automated reprocessing, as confirmed by FDA testing and independent microbiological studies.
- CDC outbreak investigations at multiple hospitals established definitive duodenoscope-to-patient CRE transmission chains using whole-genome sequencing.
- Olympus's reprocessing instructions were inadequate to prevent bacterial transmission — the FDA issued multiple safety communications confirming this finding.
- The October 2025 Olympus Urgent Field Safety Notice acknowledges that reprocessing protocols remain insufficient, with 2 deaths and 5 serious injuries reported in 2024-2025 alone.
- Transition to fully disposable or disposable-tip duodenoscopes is the only reliable way to eliminate cross-contamination risk from elevator mechanism bacterial entrapment.
Why This Matters for Your Case
The Olympus duodenoscope litigation is fundamentally a design defect and failure-to-warn case. The core claim is that Olympus designed and marketed a reusable medical device with an elevator mechanism it knew could not be adequately cleaned, provided reprocessing instructions it knew were insufficient, concealed known infection risks from hospitals and the FDA, and failed to redesign the device or transition to disposable components despite years of documented superbug outbreaks. The October 2025 field safety notice — admitting ongoing reprocessing insufficiency a decade after the first major outbreaks — strengthens both the design defect and corporate knowledge elements of plaintiff claims.
Were you infected after an ERCP procedure using an Olympus duodenoscope? Get a free case evaluation today.
Get Your Free Case ReviewThe Microbiology of Duodenoscope Contamination
The contamination mechanism in Olympus duodenoscopes involves biofilm formation — a process in which bacteria adhere to the device surface and produce a protective extracellular matrix. Once a biofilm establishes within the elevator mechanism's crevices, it becomes extremely resistant to both chemical disinfectants and mechanical cleaning. Standard high-level disinfection using glutaraldehyde or ortho-phthalaldehyde (OPA) can kill free-floating (planktonic) bacteria but has limited efficacy against established biofilms. Bacteria within the biofilm exist in a metabolically dormant state that renders them up to 1,000 times more resistant to antimicrobial agents than their planktonic counterparts.
The specific organisms most commonly identified in duodenoscope contamination include Klebsiella pneumoniae (CRE strains), Escherichia coli (including extended-spectrum beta-lactamase or ESBL producers), Pseudomonas aeruginosa, and Enterobacter species. Post-market surveillance studies ordered by the FDA found that between 3 and 35 percent of properly reprocessed duodenoscopes harbored organisms of concern — a contamination rate that would be unacceptable for any other medical device that contacts sterile body sites. The wide range in contamination rates reflects differences in reprocessing protocols, scope age, and surveillance methodology across study sites.
Corporate Knowledge and Failure to Warn
Discovery in duodenoscope litigation has revealed that Olympus was aware of contamination risks associated with the elevator mechanism design well before the 2015 UCLA outbreak brought the issue to public attention. Internal Olympus documents show that the company received adverse event reports linking its duodenoscopes to post-ERCP infections as early as 2012. Rather than issuing prompt safety communications or redesigning the elevator mechanism, Olympus chose to revise its reprocessing instructions incrementally — adding new cleaning steps and brushing protocols that, as subsequent outbreaks demonstrated, were insufficient to eliminate the fundamental design problem.
The FDA cited Olympus multiple times for failing to comply with medical device reporting requirements — the federal regulations that require manufacturers to report deaths, serious injuries, and malfunctions to the agency within specific timeframes. In warning letters issued in 2015 and subsequent years, the FDA documented patterns of delayed and incomplete reporting by Olympus. The agency characterized the company's reporting failures as reflecting a troubling disregard for patient safety. These regulatory findings form a significant component of the failure-to-warn claims in litigation, as they demonstrate that Olympus not only knew about the contamination problem but actively failed to communicate the severity of the risk to hospitals and patients who depended on accurate safety information.
Internal Documents & Evidence
UCLA Ronald Reagan Medical Center CRE Outbreak Investigation — 7 Infected, 3 Dead
“In February 2015, UCLA Ronald Reagan Medical Center disclosed that 7 patients had been infected and at least 179 potentially exposed to CRE (carbapenem-resistant Enterobacteriaceae) during ERCP procedures performed with contaminated Olympus TJF-Q180V duodenoscopes. Three patients died. The investigation confirmed through whole-genome sequencing that the CRE strain was identical across affected patients and was transmitted via the duodenoscope's elevator mechanism — definitively establishing the device as the infection vector. UCLA confirmed it had followed Olympus's reprocessing instructions exactly, meaning the infections resulted from device design rather than user error.”
Impact: The UCLA outbreak was the catalytic event for Olympus duodenoscope litigation. It provided the first high-profile, publicly documented proof that Olympus's reprocessing instructions were inadequate to prevent lethal infections. The outbreak triggered FDA safety communications, congressional investigation, DOJ criminal prosecution, and hundreds of lawsuits. The whole-genome sequencing evidence — proving identical bacterial strains across patients — established the causation chain that is now standard in duodenoscope litigation.
Senate HELP Committee Investigation — Olympus Concealed European Infection Reports
“The Senate HELP Committee's investigation revealed that Olympus Corporation received reports of duodenoscope-linked superbug infections from European hospitals as early as 2012 — years before the 2015 UCLA outbreak. Internal Olympus communications obtained by the committee showed that the company tracked these European infection reports but did not file required Medical Device Reports (MDRs) with the U.S. FDA or issue safety notifications to American hospitals. The committee found a systematic pattern of delayed adverse event reporting and corporate decision-making that prioritized protecting market position over patient safety disclosure.”
Impact: The Senate investigation's findings of concealment are the most damaging evidence in the failure-to-warn element of duodenoscope litigation. They establish that Olympus had actual knowledge of the infection risk before U.S. patients died, and made a corporate decision not to disclose that knowledge. This evidence supports punitive damages claims in jurisdictions that allow them, and it undermines any Olympus defense that the infection risk was unforeseeable or that the company acted promptly upon learning of the problem.
Olympus October 2025 Urgent Field Safety Notice — Reprocessing Still Insufficient After a Decade
“In October 2025, Olympus Corporation issued an Urgent Field Safety Notice acknowledging that its duodenoscope reprocessing protocols remain insufficient to prevent patient-to-patient infection transmission. The notice disclosed that 2 patients died and 5 suffered serious injuries in 2024-2025 from infections linked to reprocessed duodenoscopes — a full decade after the UCLA outbreak and nine years after Olympus's $85 million criminal guilty plea. The notice effectively concedes that the fundamental design defect identified in 2015 has never been corrected, and that the cleaning instructions Olympus provides with its devices still do not achieve adequate decontamination.”
Impact: The October 2025 field safety notice is the most significant recent development in Olympus duodenoscope litigation for three reasons: (1) it is a manufacturer admission that its own product cannot be safely cleaned — the core allegation of every plaintiff case; (2) it confirms ongoing patient deaths and injuries, establishing that harm is not historical but continuing; and (3) it reopens the litigation window for patients infected in 2024-2025, who now have fresh claims supported by the manufacturer's own concession. For existing litigation, the notice undermines any Olympus defense that post-2016 corrective actions resolved the contamination risk.
Were you infected after an ERCP procedure using an Olympus duodenoscope? Get a free case evaluation today.
Get Your Free Case ReviewRegulatory Actions Against Olympus Duodenoscopes
The Olympus TJF-Q180V duodenoscope has been the subject of extensive FDA regulatory action, congressional investigation, CDC outbreak responses, and a landmark Department of Justice criminal prosecution. The regulatory record documents a pattern of known contamination risks, delayed manufacturer response, and ongoing patient safety failures spanning more than a decade.
FDA Safety Communication: Duodenoscope Reprocessing Inadequacy
Following the UCLA Ronald Reagan Medical Center CRE outbreak that infected 7 patients and killed 3, the FDA issued a safety communication alerting healthcare facilities that the design of duodenoscopes may impede effective reprocessing. The FDA acknowledged that even meticulous adherence to manufacturer reprocessing instructions may not fully eliminate contamination risk. This was the first formal FDA acknowledgment that the device design itself — not user error — was the root cause of infection transmission.
FDA Ordered Olympus to Conduct Post-Market Surveillance Studies
The FDA issued a Section 522 post-market surveillance order requiring Olympus and other duodenoscope manufacturers to conduct studies evaluating the effectiveness of their reprocessing instructions in real-world clinical settings. Results confirmed unacceptably high contamination rates even at hospitals following manufacturer protocols exactly, validating the design defect theory central to plaintiff litigation.
Senate HELP Committee Investigation of Olympus
The Senate Health, Education, Labor, and Pensions (HELP) Committee investigated Olympus Corporation's handling of duodenoscope infection reports. The investigation revealed that Olympus had received reports of duodenoscope-linked infections in Europe as early as 2012 but failed to report them to the FDA or warn U.S. hospitals. The committee's findings of concealment and delayed reporting became central to failure-to-warn claims in subsequent litigation.
DOJ Criminal Prosecution — Olympus Guilty Plea and $85M Fine
Olympus Corporation of the Americas pleaded guilty to a federal criminal misdemeanor charge for distributing adulterated and misbranded medical devices. Olympus admitted it sold TJF-Q180V duodenoscopes with reprocessing instructions that had not been cleared by the FDA. The company paid $85 million in criminal fines and penalties — one of the largest criminal penalties ever assessed against a medical device company for device-related conduct.
Multiple FDA Warning Letters to Olympus
The FDA issued multiple warning letters to Olympus citing failures in adverse event reporting, quality system compliance, and corrective action implementation. Warning letters documented that Olympus failed to file required Medical Device Reports (MDRs) for duodenoscope-linked infections in a timely manner, and that the company's corrective actions were insufficient to address the root cause of contamination.
FDA Recommendation to Transition to Disposable Duodenoscopes
The FDA issued updated guidance recommending that healthcare facilities transition from reusable duodenoscopes to models with disposable elevator components or fully disposable designs. This guidance effectively acknowledged that the fundamental design of reusable duodenoscopes — including the TJF-Q180V — cannot be made safe through reprocessing alone, validating the core design defect allegation in plaintiff litigation.
Urgent Field Safety Notice: Reprocessing Still Insufficient
In October 2025, Olympus issued an Urgent Field Safety Notice acknowledging that its reprocessing protocols for duodenoscopes remain insufficient to prevent patient infection. The notice disclosed 2 deaths and 5 serious injuries in 2024-2025 linked to duodenoscope contamination. This admission — made a full decade after the 2015 UCLA outbreak — is the most damaging manufacturer concession to date, confirming that Olympus continued to sell devices it knew could not be safely cleaned.
Significance Legend
Key Takeaway
The regulatory record against Olympus duodenoscopes is among the most comprehensive in medical device history: FDA safety communications, a congressional investigation documenting concealment, an $85 million criminal guilty plea, post-market surveillance confirming reprocessing failure, and — most recently — Olympus's own October 2025 admission that its cleaning protocols remain inadequate. This record establishes both the design defect and the corporate knowledge elements essential to plaintiff claims, while the 2025 field safety notice reopens the litigation window for recently injured patients.
Olympus Corporation: Market Dominance and Concealment
Olympus Corporation, the Tokyo-based optics and medical technology conglomerate, has dominated the global endoscope market for decades. At the time of the major CRE outbreaks, Olympus controlled approximately 85% of the U.S. duodenoscope market — a near-monopoly that left hospitals with virtually no alternative devices even after infection risks became known. The litigation record reveals a corporation that prioritized market dominance over patient safety, concealed known infection reports from regulators and hospitals, and resisted design changes that would have prevented deaths.
Timeline: Olympus Corporation
Early European Infection Reports Received by Olympus
Olympus received reports from European hospitals documenting duodenoscope-linked superbug infections. Internal company communications later revealed by the Senate HELP Committee investigation showed that Olympus tracked these reports but did not disclose them to the U.S. FDA or American hospitals, despite legal obligations to report adverse events. This concealment period is central to failure-to-warn claims.
Virginia Mason Medical Center Outbreak — One of the First U.S. Cases
Virginia Mason Medical Center in Seattle reported a CRE outbreak linked to Olympus duodenoscopes. At least 39 patients were exposed and multiple patients developed infections. This was among the earliest documented U.S. outbreaks and prompted the hospital to implement enhanced surveillance — but Olympus did not issue broader warnings to other facilities.
UCLA Ronald Reagan CRE Outbreak — 7 Infected, 3 Deaths
The UCLA Ronald Reagan Medical Center reported that 7 patients were infected and 3 died from CRE superbug infections transmitted via contaminated Olympus TJF-Q180V duodenoscopes. The outbreak received national media coverage and triggered FDA safety communications, congressional investigations, and the wave of litigation that continues today. UCLA's investigation confirmed the elevator mechanism as the contamination source.
Senate Investigation Reveals Olympus Concealment
The Senate HELP Committee investigation documented that Olympus received duodenoscope infection reports from Europe years before U.S. outbreaks but failed to report them to the FDA or warn American hospitals. The investigation found a pattern of delayed adverse event reporting and corporate prioritization of market position over transparency.
Olympus Pleads Guilty — $85 Million Criminal Fine
Olympus Corporation of the Americas pleaded guilty to federal criminal charges for distributing adulterated and misbranded duodenoscopes with FDA-unchecked reprocessing instructions. The $85 million penalty was among the largest criminal fines ever assessed against a medical device company. The guilty plea established that Olympus knowingly distributed devices with inadequate cleaning protocols.
Major Litigation and Individual Verdicts Exceeding $6.6 Million
Hundreds of lawsuits were filed against Olympus by patients infected with CRE and other multidrug-resistant organisms during ERCP procedures. Individual jury verdicts exceeded $6.6 million. Many cases were settled confidentially. Litigation established the legal framework for design defect, failure to warn, and negligent misrepresentation claims against duodenoscope manufacturers.
Olympus Issues Urgent Field Safety Notice — Admits Ongoing Risk
Olympus issued an Urgent Field Safety Notice acknowledging that reprocessing protocols for its duodenoscopes remain insufficient. The notice disclosed 2 patient deaths and 5 serious injuries in 2024-2025 from duodenoscope-linked infections. This admission — a decade after the first major outbreaks — confirms that the design defect was never corrected and that patients continue to be harmed by the same fundamental problem.
Concealment, Delayed Action, and Ongoing Patient Harm
The Olympus duodenoscope litigation reveals a decade-long pattern of corporate knowledge, concealment, and resistance to design changes. Olympus received European infection reports as early as 2010-2012 but did not disclose them to the FDA or U.S. hospitals. After the 2015 UCLA outbreak forced public disclosure, Olympus resisted transitioning to disposable-tip designs that would have eliminated the contamination risk. The company's 2016 criminal guilty plea established knowing distribution of devices with inadequate cleaning protocols. Most damaging, the October 2025 field safety notice confirms that — nearly a decade later — Olympus still has not solved the problem, and patients are still dying.
- Senate HELP Committee investigation documented that Olympus concealed European infection reports from the FDA and U.S. hospitals for years before the UCLA outbreak.
- Olympus's $85 million criminal guilty plea established that the company knowingly distributed duodenoscopes with reprocessing instructions that had not been FDA-cleared.
- Internal Olympus documents produced in litigation revealed corporate awareness of elevator mechanism contamination risk and resistance to costly design modifications.
- The October 2025 Urgent Field Safety Notice — disclosing 2 deaths and 5 serious injuries in 2024-2025 — demonstrates that Olympus has failed to correct the fundamental design defect despite a decade of documented patient harm.
- Hospitals that continued using Olympus duodenoscopes after 2015 have faced their own litigation from infected patients, creating a secondary wave of institutional liability claims.
Key Takeaway
Olympus Corporation's conduct in the duodenoscope litigation represents one of the most egregious examples of medical device corporate malfeasance in recent history: a company that knew its flagship product harbored a lethal contamination risk, concealed that knowledge from regulators and hospitals, pleaded guilty to criminal charges, paid an $85 million fine — and then continued selling the same fundamentally defective device for another decade, resulting in additional deaths confirmed by its own 2025 safety notice.
Litigation Timeline
Olympus begins receiving adverse event reports linking TJF-series duodenoscopes to post-ERCP infections
Olympus begins receiving adverse event reports linking TJF-series duodenoscopes to post-ERCP infections Source: FDA adverse event database.
UCLA Ronald Reagan Medical Center announces CRE outbreak — 179 patients exposed, 7 confirmed infections, 3…
UCLA Ronald Reagan Medical Center announces CRE outbreak — 179 patients exposed, 7 confirmed infections, 3 deaths linked to Olympus duodenoscopes Source: UCLA Health press release; CNN.
FDA issues Safety Communication warning healthcare facilities about infection risk from reprocessed…
FDA issues Safety Communication warning healthcare facilities about infection risk from reprocessed duodenoscopes Source: FDA Safety Communication.
FDA convenes advisory panel confirming elevator mechanism design creates contamination risks
FDA convenes advisory panel confirming elevator mechanism design creates contamination risks Source: FDA advisory panel proceedings.
First individual lawsuits and hospital claims filed against Olympus Corporation
First individual lawsuits and hospital claims filed against Olympus Corporation Source: Court filings.
FDA orders mandatory post-market surveillance studies for all duodenoscope manufacturers
FDA orders mandatory post-market surveillance studies for all duodenoscope manufacturers Source: FDA order.
FDA clears Olympus TJF-Q180V with design modifications intended to reduce infection risk
FDA clears Olympus TJF-Q180V with design modifications intended to reduce infection risk Source: FDA clearance announcement.
Washington state jury orders Olympus to pay $6.6 million to Virginia Mason Medical Center for superbug…
Washington state jury orders Olympus to pay $6.6 million to Virginia Mason Medical Center for superbug outbreak Source: King County Superior Court verdict.
Olympus settles wrongful death claims from families of two patients who died at Virginia Mason…
Olympus settles wrongful death claims from families of two patients who died at Virginia Mason (confidential amounts) Source: Court records.
FDA recommends transition to duodenoscopes with disposable components or fully disposable models
FDA recommends transition to duodenoscopes with disposable components or fully disposable models Source: FDA recommendation.
Olympus issues voluntary advisory notice and Class 1 recall for endoscope accessory MAJ-891 due to…
Olympus issues voluntary advisory notice and Class 1 recall for endoscope accessory MAJ-891 due to contamination risk (120 injuries, 1 death reported) Source: FDA recall database.
Olympus issues Urgent Field Safety Notice for TJF-Q190V, TJF-Q290V, and TJF-Q170V — reports 2 deaths and 5…
Olympus issues Urgent Field Safety Notice for TJF-Q190V, TJF-Q290V, and TJF-Q170V — reports 2 deaths and 5 serious injuries from 2024-present, admits reprocessing remains insufficient Source: Olympus Field Safety Notice.
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Sources & References
- UCLA Ronald Reagan Medical Center CRE outbreak: 179 patients exposed, 7 confirmed CRE infections, at least 3 deaths (2015) — UCLA Health; CNN; Washington Post
- Virginia Mason Medical Center: 32 patients infected with CRE via contaminated Olympus duodenoscopes (2012-2014) — Seattle Times; Becker's Hospital Review
- $6.6 million jury verdict — Virginia Mason v. Olympus Corporation (July 2017) — King County Superior Court; Healthcare Finance News; Drugwatch
- FDA Safety Communication: Infections Associated with Reprocessed Flexible Bronchoscopes and Duodenoscopes (February 2015) — U.S. Food and Drug Administration
- FDA Recommendation: Transition to Duodenoscopes with Disposable Components (2021) — U.S. Food and Drug Administration
- CDC: Carbapenem-resistant Enterobacteriaceae classified as urgent threat with ~40-50% bloodstream infection mortality — Centers for Disease Control and Prevention
- Olympus Urgent Field Safety Notice (October 2025): 2 deaths, 5 serious injuries reported 2024-present — Olympus Corporation Field Safety Notice
- FDA Warning Letters to Olympus for failures in medical device reporting requirements — U.S. Food and Drug Administration