The escalating litigation against the manufacturer of medical technology, Olympus Corporation, over its reusable medical scopes marks a pivotal moment in product liability jurisprudence. The previous litigation resulting in settlements and trials, over a decade ago, was driven by numerous allegations of design defect, failure to warn, and systemic regulatory noncompliance. In fact, Olympus and Hisao Yabe–former senior quality manager of the corporation–pled guilty to being in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).1 Now, plaintiffs are advancing with similar claims that are grounded in liability and negligence on duodenoscope contamination, thus beginning the next wave of litigation against Olympus.
The FDA Steps in to Prevent Contaminated Scope Infection Injuries
The FDA’s Center for Devices and Radiological Health (CDRH) announced a series of corrective measures as part of its recall program in late 2024. This entailed removing certain medtech devices from the they are sold and used, and a one of Olympus-manufactured products were identified as a dangerous product, capable of causing serious harm.2 The device in question is the MAJ-891 Forceps/Irrigation Plug, which is an endoscope accessory designed to attach to certain Olympus scopes, allowing simultaneous fluid irrigation and the passage of endo-therapy instruments during procedures. It has been flagged by the FDA due to a heightened risk of patient infection, an issue that stems from incomplete reprocessing.3
Adequate Cleaning Required to Prevent Injuries and Deaths
There have been reports of approximately 120 injuries and at least one death linked to contamination following the use of the MAJ-891. Some of these injuries include, but are not limited to: urinary tract infections (UTIs), sepsis, hospitalizations, and more.4 Injuries associated with other Olympus devices are similarly tied to alleged negligence in the manufacturing of the products as well as design-related contamination risks, meaning that litigation will extend beyond duodenoscopes into multi-specialty endoscopy platforms.
Is Any Reusable Scope Safe?
This new wave signals a broader issue of product liability for Olympus Corporation. Some manufacturers only make disposable scopes. Because claims are not confined to duodenoscopes and are expanding to include multiple device categories, affected patients will likely come forward to raise awareness of the contamination risks they endured. Individuals who have experienced post-procedural complications may not yet realize the connection between their injuries and these medtech devices.
If you or a loved one suffered complications following a medical procedure, you may have legal options. Reach out to our team for a confidential consultation to learn more about your rights and whether you could be eligible for compensation.
References
1U.S. Department of Justice, “Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Misbranded Endoscopes,” Dec. 10, 2018, https://www.justice.gov/archives/opa/pr/olympus-medical-systems-corporation-former-senior-executive-plead-guilty-distributing.
2FDA, “CDRH Announces Communications Pilot to Enhance Medical Device Recall Program,” Nov. 21, 2024, U.S. Food and Drug Administration, https://www.fda.gov/medical‑devices/medical‑devices‑news‑and‑events/cdrh‑announces‑communications‑pilot‑enhance‑medical‑device‑recall‑program.
3U.S. Food & Drug Administration, “Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus,” Mar. 5, 2025, https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-endoscope-accessories-forcepsirrigation-plug-issue-olympus.
4Ibid.
