OLYMPUS ENDOSCOPE INFECTION LAWSUITS

Overview of Olympus Endoscope Lawsuits

Olympus Endoscope Infection Lawsuits involve devices allegedly linked to infection outbreaks due to inadequate cleaning and disinfection processes. Levy Konigsberg is investigating claims that Olympus endoscopes were improperly reprocessed, exposing patients to infection risks during medical procedures.

Olympus endoscopes, including duodenoscopes and related devices, are manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Olympus is a global medical technology company that develops and produces endoscopic equipment used in a wide range of diagnostic and therapeutic procedures. These devices are designed for repeated use in clinical settings and require specialized cleaning and high-level disinfection between procedures to reduce the risk of contamination and infection. These devices, however, have been linked to infection outbreaks, regulatory scrutiny, and product liability lawsuits over the past decade. 

Scientific literature, government reports, and litigation filings consistently point to one core issue: infections may occur when endoscopes are not effectively cleaned and disinfected between uses.

If you or a loved one was harmed, contact us today.

Research, Lawsuits, and Regulatory Action involving Olympus Scopes

Infection Risks Linked to Endoscopes

Flexible endoscopes are exposed to blood, mucus, and other bodily fluids during procedures and may carry millions to billions of microorganisms prior to cleaning.

Although guidelines require thorough cleaning and high-level disinfection (HLD), real-world evidence shows these processes are not always effective.

Key Findings from Recent Research

• Processing errors are common and often involve multiple steps
• Contaminants and pathogens can remain on scopes even after reprocessing
• Outbreaks have been linked to multiple types of endoscopes, not just one model
• Infection risks persist despite adherence to guidelines in some cases

A large systematic review found that approximately 19.98% of reprocessed gastrointestinal endoscopes remained contaminated when used in patients.

These findings highlight ongoing concerns that current cleaning and disinfection practices may not fully eliminate harmful microorganisms.

FDA Safety Alerts and Regulatory Action

The U.S. Food and Drug Administration (FDA) has issued multiple communications related to Olympus devices, including safety alerts, recalls, and import restrictions.

• In June 2025, the FDA announced import alerts affecting certain Olympus devices manufactured in Japan due to quality system regulation violations.

Devices include:

• • Bronchoscopes
  • Ureterorenoscopes
  • Laparoscopes
  • Endoscope reprocessors

The FDA warned that manufacturing and compliance issues could affect device safety and emphasized proper inspection, maintenance, and reprocessing protocols.

• In January 2025, Olympus issued a medical device advisory involving the MAJ-891 forceps/irrigation plug—an accessory used with certain endoscopes. The advisory warned of contamination risks from improper reprocessing, with reported patient injuries and one death.

Duodenoscope Litigation

Lawsuits began emerging after infection outbreaks in U.S. hospitals starting around 2010.

According to reported data:

• Over 400 patients were infected between 2010 and 2015
• At least 35 deaths were linked to infections
• More than 36 hospitals experienced outbreaks

Many infections involved antibiotic-resistant “superbugs,” such as CRE (carbapenem-resistant Enterobacteriaceae), which carry high mortality rates.

Legal Outcomes

• A jury awarded $6.6 million in damages in a 2017 case
• Olympus has entered confidential settlements in multiple lawsuits
• Federal investigations led to $85 million in penalties related to reporting failures

The underlying safety concerns continue to drive new scrutiny and potential litigation.

Legal Representation for Olympus Scope Lawsuits: Contact a Medical Device Attorney

If you or a loved one developed an infection following a procedure involving an Olympus endoscope or related device, you may be entitled to compensation.

An experienced product liability attorney can help determine:

• Whether a defective device contributed to the infection
• If proper cleaning and safety protocols were followed
• What legal options may be available for you

Why Choose Levy Konigsberg?

• Experience: With decades of experience in complex litigation, our attorneys are well-equipped to handle product liability lawsuits.
• Results: We have recovered billions of dollars on behalf of our clients in mass tort and product liability cases.
• Personalized Attention: Each case is unique, and we provide personalized legal strategies tailored to our clients’ needs.

There are time limits for filing claims, so don’t wait to seek legal advice.