Olympus Duodenoscope Infection Lawsuits: The “Superbug” Crisis Continues

If you or a loved one suffered a severe bacterial infection—such as CRE, E. coli, or Sepsis—following an endoscopic procedure (ERCP), you may have been exposed to a contaminated medical device.

For over a decade, Olympus Medical Systems has faced allegations that its specialized duodenoscopes are impossible to clean thoroughly, trapping deadly bacteria and transmitting it between patients. Despite criminal guilty pleas and massive fines in the past, new evidence from late 2025 proves the danger is not over.

New Evidence: The October 2025 Urgent Safety Notice

As of October 17, 2025, Olympus issued an Urgent Field Safety Notice admitting that current reprocessing (cleaning) protocols were insufficient to stop infections.

In this critical admission, Olympus acknowledged that “ongoing assessment… to address positive cultures and infections” required them to update their training manuals and inspection guides. The notice explicitly states:

“The potential risk related to improper and/or incomplete reprocessing of Olympus duodenoscopes includes exposure to a contaminated device which may result in patient infection.”

This admission is devastating because it confirms that the cleaning instructions hospitals were following prior to October 2025 may have been inadequate to protect patients.

Admitted Injuries and Deaths

In the same 2025 notice, Olympus confirmed that from “2024 to present,” they received reports of:

• 2 deaths potentially related to the use of TJF duodenoscopes.
• 5 serious injuries resulting from infection or positive bacterial cultures.

The Core Defect: Why These Scopes Are Dangerous

The specific devices involved—the TJF-Q190V, TJF-Q290V, and TJF-Q170V 6—feature a complex “elevator” mechanism at the tip. This moving part is necessary for doctors to manipulate tools during procedures, but it creates microscopic crevices that are notoriously difficult to disinfect.

For years, hospitals cleaned these devices according to Olympus instructions, yet bacteria survived. Now, in the October 2025 update, Olympus is finally recommending that hospitals use “10X magnification tools” to inspect the device tip for irregularities.

The Legal Question: If 10X magnification is required to ensure safety now, were the “naked eye” inspections performed on patients for the last decade negligent by design?

A History of Negligence: From DOJ Convictions to FDA Bans

The 2025 safety alerts are part of a disturbing pattern of behavior by the manufacturer.

• 2018 DOJ Guilty Plea: Olympus Medical Systems Corp. pleaded guilty to failing to file required adverse event reports involving infections. They were fined $85 million for concealing outbreaks in Europe while continuing to sell the devices in the US.
• June 2025 FDA Import Alert: The FDA issued an import alert for 58 models of Olympus devices manufactured in Japan, preventing future shipments due to safety compliance failures.
• Active Outbreaks (2024-2025): We are currently investigating infection clusters at major medical centers, including reports linked to Vanderbilt, UCLA, and Providence.

Do I Qualify for the Olympus Lawsuit?

We are currently evaluating claims for patients who underwent endoscopic procedures as far back as 2015. You may have a claim if you meet any of the following criteria:

• Severe Infection (Sepsis/Organ Failure): You had a scope procedure since 2015 and required hospitalization for an infection treated with IV antibiotics within one year of the procedure.
• Superbug Diagnosis: You were diagnosed with a “superbug” (drug-resistant infection like CRE or E. coli) within 180 days of your scope procedure.
• Bowel/Organ Perforation: You suffered a perforation (puncture) of the intestinal wall or organ during a scope procedure since 2015. Note: While often labeled as “surgical error,” this can frequently be caused by the device’s mechanical failure.
• Notice of Exposure: You received a letter from a hospital notifying you of potential exposure to a contaminated scope, followed by an infection diagnosis within the last year.

Important: Even if your procedure was years ago, the “Statute of Limitations” may not have started until you discovered the link between the scope and your injury. Contact us immediately to verify your eligibility.

Why You Need an Attorney Now

Medical device manufacturers often blame hospital staff for “improper cleaning” to avoid liability. The October 2025 Field Safety Notice attempts to shift this burden by claiming they are “reminding users to closely follow… instructions”.

However, when a device is designed in a way that makes consistent cleaning impossible—or when the manufacturer provides inadequate instructions for years—the manufacturer is liable.

Contact Nigh Goldenberg today. We are analyzing the connection between the October 2025 recall and infections that occurred throughout 2024 and 2025. Do not let the statute of limitations expire on your claim.