Olympus Scopes Lawsuit Investigation

Berger Montague PC is investigating claims on behalf of individuals who suffered serious complications from contaminated Olympus endoscopes or duodenoscopes. If you were injured, you may have legal options and our team is here to help.

What are the scopes?

Endoscopes are flexible tubular medical instruments with a light and camera commonly used to examine the bladder, urethra, uterus, cervix, pancreas, bile ducts, and colon during medical procedures. Duodenoscopes are a type of endoscope that has side-viewing, instead of forward-viewing, cameras used primarily for endoscopic retrograde cholangiopancreatography, or ERCP. Approximately 500,000 procedures are done each year in the United States with duodenoscopes, per the FDA. The medical devices are reprocessed by cleaning, disinfecting, or sterilizing so that they can be reused.

The scopes are used in the following procedures:

• Colonoscopies
• Bronchoscopies
• Enteroscopies
• Gastroscopies
• Endoscopic retrograde cholangiopancreatography

Olympus Corporation is based in Japan and holds approximately 70 percent of the global gastrointestinal endoscope market. It also manufactured a reusable endoscope accessory, known as model MAJ-891 Forceps/Irrigation Plug, that attaches to the instrument channel port of certain Olympus endoscopes to aid in irrigation and the use of endo-therapy accessors.

FDA Recalls

On January 29, 2025, the U.S. Food and Drug Administration (FDA) and Olympus announced a voluntary Advisory Notice and recall of the model MAJ-891 endoscope accessory. The MAJ-891 was discontinued in 2022 from the U.S. market, but it continued to be used until recently.

According to the notice, the accessory is at an increased risk of contamination during reprocessing, or cleaning. The component is a small device with several crevices, seams, and moving parts. It is directly in contact with a patient’s internal tissue and can becomes contaminated with biological material, requiring the device to be thoroughly cleaned and sanitized.

Improper and/or incomplete reprocessing of the MAJ-891 can result in patient injury, specifically, infections. The FDA has received 120 reports of injuries and one death linked to reprocessing the device.

Duodenoscopes also have many small parts and when they are not thoroughly cleaned and disinfected the device may cause potentially fatal infections. The FDA released interim results from its post-market surveillance studies that showed higher-than-expected contamination rates after duodenoscope reprocessing. It found that up to 3% of properly collected samples tested positive for high-concern organisms and up to 3% tested positive for enough low-concern organisms to indicate a reprocessing failure.

The FDA sent a letter to Olympus in March 2014 regarding a design change that may cause contamination and ordered the company to obtain FDA clearance within 30 business days. The FDA then released a safety communication noting that the manufacturer-recommended cleaning procedures for duodenoscopes may not be sufficient to properly sterilize the instruments due to their design. That same year, the FDA was notified that Olympus Corporation failed to alert regulators that patients were developing superbug infections following procedures with a duodenoscope

Olympus recalled its original model duodenoscope in January 2026.

Injuries Linked to Olympus Scopes

Patients exposed to a contaminated endoscope duodenoscope may suffer the following injuries:

• Severe viral and bacterial infections
• Organ failure
• Sepsis
• Death

Consult With Us

At Berger Montague, a large team of talented lawyers and professional staff are assigned to this important litigation. We are available to speak with you free of charge about your potential claims. If we decide to represent you in a lawsuit, we will enter into a written contingent fee agreement with you. A contingent fee agreement means we only get paid if we win, and that we will receive our fees from the amount paid by the defendants in the case.

About Berger Montague

Berger Montague is one of the nation’s preeminent law firms focusing on complex civil litigation, class actions, and mass torts in federal and state courts throughout the United States. With more than $2.4 billion in 2025 post-trial judgments alone, the Firm is a leader in the fields of complex litigation, antitrust, consumer protection, defective products, environmental law, employment law, securities, and whistleblower cases, among many other practice areas. For over 55 years, Berger Montague has played leading roles in precedent-setting cases and has recovered over $50 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago; Malvern, PA; Minneapolis; San Diego; San Francisco; Toronto, Canada; Washington, D.C., and Wilmington, DE.