How an Olympus Colonoscopy and Endoscopy Scope may Lead to Infections

The lawsuits involve claims of contaminated or defectively designed Olympus Scopes.  These claims allege that certain reusable medical devices widely distributed in recent decades were defectively designed in ways that allowed bacteria and biological material to remain trapped inside the device.

Endoscopes and similar devices are important tools commonly used by medical professionals to diagnose and treat various conditions. Different scopes are used for specific parts of the body. These flexible devices are often “reprocessed,” meaning they are disinfected and reused for future procedures.

Unlike surgical instruments that can be fully disassembled and sterilized, some endoscopes and duodenoscopes contain complex internal channels, hinges, and moving components that can trap bacteria or bodily fluids, even after hospitals attempt to clean and disinfect them between patients.

As a result, contamination inside the device may allow bacteria from one patient to be transmitted to another patient during a later procedure, potentially leading to serious infections.

When bacteria become trapped inside the internal channels or mechanical components of a scope, it may be introduced into the digestive tract, bile ducts, lungs, or bloodstream during a later procedure. These infections can range from localized bacterial illnesses to life-threatening systemic infections.

Some of the design issues cited in surgical scope lawsuits include:

• Elevator mechanisms that create small crevices where bacteria may accumulate
• Narrow internal channels that may retain bodily fluids and biological material
• Sealed device components that cannot be easily inspected for contamination
• Complex internal structures that make thorough sterilization difficult

Lawsuits allege manufacturers knew these designs created contamination risks but continued marketing the devices to hospitals.

Since 2013, the FDA has been aware of the risk of infection from reprocessed scopes, even those that had been sterilized using proper procedures.The Olympus scopes lawsuits involve claims of contaminated or defectively designed Olympus endoscopes. Scope patients developed serious infections, including HIV, Tuberculosis, and superbugs, after common medical scoping procedures. Those procedures include: colonoscopies, bronchoscopies, enteroscopies, and gastroscopies.

U.S. Food & Drug Administration (FDA) has issued an import alert to stop new products from entering the country.

On June 24, 2025, the U.S. Food and Drug Administration (FDA) issued an import alert covering 58 models of Olympus endoscope devices manufactured in Japan, citing concerns related to manufacturing and compliance.

FDA import alerts are used to stop products that may violate U.S. safety standards from entering the country.

Previously, in a November 2022 warning letter, the FDA detailed investigative findings that a facility that manufactures Olympus devices, run by subsidiary Aizu Olympus Co., Ltd., violated multiple “Quality System” regulations. The violations included the following:

• Failure to fully test and validate the designs of its products
• Failure to properly document and test all steps of the manufacturing process to ensure they are safe
• Failure to enact written procedures for reporting issues and adverse effects related to its medical devices

The FDA’s Center for Devices and Radiological Health explained in a January 2023 release that the warning letters issued to Olympus and its subsidiaries were part of an effort to ensure manufacturers of reprocessed endoscopes followed new guidelines instituted in response to infections caused by the re-use of these devices.

Several Olympus endoscopes and accessories have been linked to FDA recalls, safety alerts, and infection investigations over the past decade.

Olympus Endoscope Recall

Olympus issued a recall for the MAJ-891 forceps/irrigation plug in December 2024, which is a reusable accessory for certain Olympus endoscopes. Regulators determined the device could trap bacteria and biological material if it was not properly disassembled and cleaned.

The recall followed reports linking the device to 120 patient injuries and one death, raising concerns that contaminated endoscope components could expose patients to serious infections.

FDA Calls for Transition to Disposable Duodenoscopes Due to Infection Risks

On April 5, 2022, the FDA issued a safety communication urging hospitals to transition away from reusable duodenoscopes to models with disposable components or fully disposable designs due to ongoing infection risks.

Post-market studies found that 6.6% of reusable duodenoscopes still carried high-concern organisms after cleaning, compared to 0.5% of scopes with disposable components, highlighting persistent contamination risks even when hospitals followed reprocessing instructions.

Olympus TJF-Q190V Duodenoscope Recall

In November 2021, the FDA announced a recall of certain Olympus TJF-Q190V EVIS EXERA III duodenoscope devices, which is a reusable scope used during ERCP procedures.

The recall required updated inspection and reprocessing instructions after reports that contamination and device issues could increase infection risks.

Olympus Urological Endoscopes Warning

The FDA issued an alert in April 2021, warning healthcare providers that reprocessed urological endoscopes, including cystoscopes, cystourethroscopes, and ureteroscopes, were linked to more than 450 infection reports between 2017 and 2021, including three patient deaths.

Regulators said the infections may be related to device contamination during the reprocessing process, inadequate cleaning instructions, or possible design issues, prompting a federal investigation into the safety of the devices.

Olympus Colonoscopy and Endoscopy Scope Studies Show High Infections Rate

A growing body of medical research has examined infection risks associated with endoscopy procedures and reusable surgical scopes.

Researchers detected several high concern bacterial organisms in a sample of reprocessed Olympus scopes. The authors advised that attempts should be made to reduce contamination rates and recommended that improvements be made to manufacturer instructions for use, reprocessing training programs, and the design of reusable scope devices.

• Gastrointestinal Endoscopy (January 2025): Investigators reviewing duodenoscope contamination and detection methods reported that documented outbreaks linked to contaminated scopes infected at least 490 patients and caused 32 deaths. The study found current detection and surveillance methods may underestimate contamination levels, suggesting infection risks may be higher than reported.

• Journal of Hospital Infection (June 2025); Researchers found contaminated duodenoscopes used during ERCP procedures can transmit microorganisms to patients even when recommended cleaning protocols are followed. The study confirmed that duodenoscope-associated colonization and infection represent a recognized clinical risk tied to reusable scope design and reprocessing limitations.
• American Journal of Infection Control (July 2025): found that endoscope reprocessing failures are common and often involve serious errors across multiple cleaning steps. The study found substantial biological material often remains on the scopes after cleaning, dangerous pathogens are commonly detected and outbreaks have been linked to multiple types of endoscopes

• Infection Control & Hospital Epidemiology (March 2022): Researchers tested reprocessed duodenoscopes from 16 U.S. clinical sites and found bacterial contamination on scopes considered ready for patient use. The study concluded that current reprocessing protocols cannot reliably eliminate microbial contamination, leaving patients exposed to potential infection during ERCP procedures.

• The Lancet (August 2020): A meta-analysis of 15 studies covering 13,112 duodenoscope samples found 15.25% of patient-ready reusable duodenoscopes remained contaminated even after standard high-level disinfection. Enhanced reprocessing methods lowered contamination but still left approximately 9.2% of scopes contaminated, indicating persistent infection risk.