Olympus Scopes: Device Safety Concerns, FDA Alerts & Lawsuits

Olympus scopes are flexible tubes connected to a small camera to help doctors see inside the body. This allows for inspection and diagnosis without the need for traditional, more invasive surgery. They are made by Japanese-based Olympus Corporation.

Olympus is the leader in gastrointestinal endoscopic equipment, accounting for 70% of the global market share.

These reusable devices are used in hundreds of thousands of medical procedures every year. They can help diagnose conditions and deliver treatment.

Olympus also makes single-use accessories that attach to its scopes to assist in different procedures, including:

• Aspiration needles to retrieve tissue for a biopsy
• Distal end caps, which help maintain distance between the scope’s tip and tissue
• Irrigation plugs to channel fluids

Reusable Olympus scopes have been linked to outbreaks of superbugs because design defects make them difficult to thoroughly clean between procedures.

Some bacteria may remain on the scope and infect a new patient when it’s next used in a procedure. According to the Cleveland Clinic, common types of superbugs include:

• Carbapenem-Resistant Enterobacterales (CREs)
• Methicillin-resistant Staphylococcus aureus (MRSA)
• Tuberculosis (TB)

Superbugs are antibiotic-resistant and difficult to treat and control, making them especially dangerous.

Over the last decade, multiple hospitals have reported superbug outbreaks related to Olympus scopes. In 2015, officials at a UCLA hospital said that a CRE outbreak that contributed to two patient deaths was tied to Olympus-made duodenoscopes.

Seattle-based Virginia Mason Medical Center reported 11 patient deaths following a CRE outbreak from 2012 to 2014 linked to contaminated endoscopes.

In recent years, the Food & Drug Administration (FDA) has issued numerous alerts and even taken action against Olympus over safety concerns for some of its scope devices.

In 2023, the FDA announced that it had issued warning letters to Olympus and one of its subsidiaries after the company didn’t properly report medical device failures related to the cleaning process between scope procedures.

A couple of years later, the agency issued an import alert for dozens of Olympus scopes, preventing more of these devices from being imported into the U.S.

The FDA based its decision on continuing concerns surrounding quality regulations.

“Olympus is committed to addressing the FDA’s concerns promptly and ensuring that our products meet the highest quality standards,” the company said in a statement after the import alert was issued. “Our highest priority is providing our customers with safe and effective solutions for patient care.”

Olympus makes a wide range of scopes for examining and diagnosing conditions in different parts of the body.

Some types of scopes have been more closely tied to potential superbug risks and actions from the FDA.

Olympus Scopes in Duodenoscopy

Duodenoscopes are used to inspect the duodenum, a part of the small intestine.

Olympus duodenoscopes are among the devices most heavily linked to superbug outbreaks. They were at the center of the outbreaks in hospitals in Washington and California.

Duodenoscopes were at the center of a significant wave of litigation following the hospital outbreaks. Olympus eventually agreed to confidential settlements with multiple people who filed duodenoscope lawsuits.

Olympus Scopes in Colonoscopy

Olympus colonoscopes are used for colon cancer screenings, polyp removals, inflammatory bowel disease evaluations and more. These devices have not been as closely linked to superbug outbreaks as duodenoscopes.

Colonoscopes were not included in the FDA’s import alert in 2025.

Olympus Scopes in Bronchoscopy

Olympus bronchoscopes help medical providers examine the lungs and respiratory tract and can also be used for biopsies.

Bronchoscopes were not linked to superbug outbreaks like duodenoscopes in the 2010s, but have now joined the expanding list of devices linked to quality issues after they were included in the FDA’s 2025 import alert.

Of the nearly 60 Olympus scopes whose imports were halted, more than 20 were types of bronchoscopes.

Olympus has been at the center of numerous lawsuits over claims that design defects in its scopes prevented them from being properly disinfected, leading to the spread of serious superbug infections like CRE.

The company has faced lawsuits from both individuals and hospitals. In 2017, Olympus was ordered to pay $6.6 million to Virginia Mason Medical Center after 11 patients died from a superbug outbreak.

The Seattle hospital was also told to turn over $1 million of that payout to the family of a patient who died during the outbreak.

Olympus confidentially settled other scope lawsuits and, by 2021, was no longer making provisions for the litigation.

But a new wave of lawsuits is expected to emerge following the FDA’s import ban and other recent safety notices.

In 2025, Olympus issued an urgent notice regarding multiple types of duodenoscopes after receiving two reports of deaths connected to the devices since 2024. The company issued updated cleaning instructions for the duodenoscope models in question.

Lawyers are now investigating lawsuits over new claims that patients who underwent colonoscopies, ERCP and other scope procedures developed severe complications. Issues that are being investigated include sepsis, abscesses, organ failure and death.

Also included are claims that patients may have developed tuberculosis or were infected with HIV following Olympus scope procedures.

If you underwent an Olympus scope procedure and went on to develop a superbug infection, tuberculosis or HIV, you may be eligible to file a lawsuit.

One of the first steps is to gather documentation related to what happened. This can include medical records, treatment of your infection and possibly the model or type of Olympus scope that was used in your procedure.

If you’re not sure where to start, an attorney can help you determine what you need to file a lawsuit and how to track down that information.