Olympus Duodenoscope Lawsuit Lawsuit Tracker

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure performed roughly 500,000 times per year in the United States. It uses a specialized endoscope called a duodenoscope to visualize and treat conditions of the bile ducts and pancreas — including gallstones, tumors, and blockages. Olympus Corporation has dominated the duodenoscope market for decades, holding an estimated 85 percent or more of the U.S. market share. The Olympus TJF-Q180V and its successor models (TJF-Q190V, TJF-Q290V) feature a movable elevator mechanism at the distal tip that allows physicians to precisely manipulate guidewires and instruments during the procedure. That elevator mechanism is at the heart of a design defect that has infected hundreds of patients with deadly superbug bacteria. The elevator's sealed channel creates microscopic crevices where tissue, blood, and bacteria become trapped during procedures. These crevices cannot be adequately cleaned using the reprocessing (sterilization) methods specified by Olympus — a fact the company has now acknowledged in multiple safety notices. The bacteria that survive reprocessing include carbapenem-resistant Enterobacteriaceae (CRE), which the CDC has classified as a nightmare bacteria because it resists nearly all available antibiotics and carries a mortality rate of 40 to 50 percent in bloodstream infections. Superbug outbreaks linked to Olympus duodenoscopes have been documented at more than 40 hospitals worldwide, including UCLA Ronald Reagan Medical Center, Virginia Mason Medical Center in Seattle, Cedars-Sinai Medical Center, and Advocate Lutheran General Hospital. The FDA has issued multiple safety communications, required post-market surveillance, and in 2021 recommended that all healthcare facilities transition to duodenoscopes with disposable components or fully disposable models. In October 2025, Olympus issued yet another Urgent Field Safety Notice admitting that reprocessing remains inadequate and recommending 10x magnification inspection of device tips. Litigation against Olympus began in 2015 and has included individual lawsuits, hospital claims, and wrongful death actions. The primary defendants are Olympus Corporation (Tokyo) and Olympus Corporation of the Americas.