Olympus medical scopes blocked by FDA following infection risks

Olympus duodenoscopes medical device recall ERCP infection FDA import block medical device litigation

The FDA has blocked 58 Olympus products manufactured at the company’s Aizu facility in Japan from entering the United States. This action follows a Class II recall of 7,023 TJF-Q190V duodenoscopes due to risks of persistent contamination and infection.

Duodenoscopes are reusable medical instruments used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions in the bile ducts and pancreas. Because these devices feature complex internal channels, valves, and seals, they are difficult to clean and can harbor biological material such as blood or mucus between patients.

Since 2013, these devices have been linked to hundreds of infections, including carbapenem-resistant infections which carry a mortality rate near 50%. At least 35 deaths have been attributed to contaminated scopes. Olympus currently maintains approximately 70% of the global market for these instruments.

Entities

Olympus Corporation · U.S. Food and Drug Administration

Sources

When a Device Maker Fails to Warn About Scope Infection Risk [www.lgbtqandall.com]

9 days ago

Duodenoscope Infection Lawsuit | ERCP Recall Lawyer [www.schmidtlaw.com]

10 days ago