The Core Allegation: A Design That Can’t Be Cleaned
Duodenoscopes are flexible endoscopes used in hundreds of thousands of procedures each year to diagnose and treat conditions of the bile ducts, gallbladder, pancreas, and liver. The specific design feature at the center of most lawsuits is the elevator channel — a small mechanical component at the tip of the scope that, plaintiffs allege, cannot be adequately cleaned and disinfected between patients because of its complex, recessed structure.
Senate investigators found that by early 2013, Olympus had received two independent laboratory reports demonstrating that certain scope models could harbor and spread bacteria even after proper cleaning procedures — and failed to inform the FDA, hospitals, physicians, or patients about that risk until February 2015. During that gap, outbreaks occurred at multiple hospitals across the United States.
Outbreaks, Deaths, and Legal Consequences
In the early 2010s, numerous U.S. hospitals experienced superbug outbreaks linked to Olympus duodenoscopes, including UCLA’s Ronald Reagan Medical Center, Cedars-Sinai Medical Center, Virginia Mason Medical Center in Seattle, Advocate Lutheran General Hospital outside Chicago, and UPMC Presbyterian in Pittsburgh. According to the U.S. Senate Health, Education, Labor, and Pensions Committee, approximately 250 patients developed carbapenem-resistant Enterobacteriaceae (CRE) infections — a superbug with a roughly 50% survival rate — from contaminated endoscopes.
In 2017, a jury ordered Olympus to pay $6.6 million to Virginia Mason Medical Center after a superbug outbreak resulted in patient deaths, with $1 million directed to the family of one victim. Olympus was subsequently fined more than $85 million by the U.S. Department of Justice for failing to file required adverse-event safety reports with the FDA — a legal obligation the company and a former executive admitted violating when they entered guilty pleas in a federal criminal case.
The FDA Import Alert and the Second Wave of Litigation
On June 24, 2025, the FDA issued import alerts covering 58 models of Olympus medical devices manufactured at the company’s Aizu facility in Japan — including ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors — citing ongoing Quality System regulation violations and compliance failures [1]. An import alert allows the FDA to detain products at the border without physical examination — a significant enforcement tool that signals serious and unresolved compliance concerns.
In October 2025, Olympus issued an Urgent Field Safety Notice acknowledging that current reprocessing protocols were insufficient to prevent infections. That notice, combined with the FDA import alert, has fueled a new wave of lawsuits filed by patients who developed infections, sepsis, or other serious complications after endoscopic procedures involving Olympus devices.
Injuries Associated With Contaminated Olympus Scopes
Patients who developed infections after Olympus scope procedures have reported a wide range of serious complications, including CRE infections, E. coli infections, sepsis, bacteremia, C. diff, MRSA, and ESBL infections. In severe cases, these drug-resistant infections can cause organ failure, require prolonged hospitalization, and can be fatal — particularly in patients who are already immunocompromised or recovering from an underlying condition.
Mechanical failures have also been reported, including dislodging or breaking of endoscopic device components and organ or tissue perforation during procedures. Serious hemorrhaging caused by a procedure that resulted in an unplanned hospital stay, blood transfusion, or additional medical intervention may also support a legal claim.
Who May Qualify for a Lawsuit
Attorneys are currently reviewing claims from patients who underwent one of the following endoscopic procedures using Olympus equipment from 2018 to present:
- Laparoscopy
- Colonoscopy
- ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Bronchoscopy
- Upper Endoscopy
- Ureteroscopy
- Hysteroscopy
- Sinus Endoscopy
- Cystoscopy
To qualify, patients must have suffered one or more of the following injuries as a result of the endoscopic procedure:
- Organ or tissue damage or perforation
- Dislodging or breaking of an endoscopic device component
- Hemorrhaging that resulted in a prolonged or unplanned hospital stay, blood transfusion, or other medical intervention causing pain and suffering
- Death from infection or component failure
- Sepsis or bacteremia
- Bacterial infection requiring hospitalization within 90 days of the procedure
- Pneumonia or severe pulmonary infection within 90 days of the procedure
- Tuberculosis within 90 days of the procedure
- HIV diagnosis within 90 days of the procedure
- Diagnosis of a drug-resistant superbug infection (such as CRE or E. coli) within 180 days of the procedure
An endoscope-related infection may appear as quickly as 24 hours after a procedure or as late as 30 or more days afterward. Symptoms that may indicate a post-procedure infection include fever, chills, unusual pain, swelling, rash, or bleeding.
Can I File a Lawsuit?
Patients who underwent a qualifying endoscopic procedure from 2018 to present and suffered any of the injuries listed above may have significant legal options against Olympus Medical Systems Corporation. Contact an attorney promptly to have your case evaluated.
References
1. https://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers