FDA 483 - Olympus Medical Systems Corporation - September 09, 2022

During an inspection conducted from September 6 to September 9, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Olympus Medical Systems Corporation, located in Hachioji-shi, Tokyo, Japan. The inspection revealed a significant compliance issue concerning the timely submission of Medical Device Reports (MDRs).

Specifically, the FDA observed that Olympus failed to submit 37 MDRs within the required 30-day timeframe after becoming aware of information suggesting their marketed devices, particularly those from the Cysto-Nephro Scope and Uretero-Reno Scope product families, may have caused or contributed to a death or serious injury. These late reports stemmed from complaints received between August 2020 and March 2022. The FDA noted this as a recurring observation, highlighting a persistent issue in the company's post-market surveillance system.

This observation indicates a deviation from the regulatory framework governing medical device reporting, which is critical for ensuring patient safety and product quality. As per the FDA 483 process, Olympus Medical Systems Corporation is expected to thoroughly investigate these observations, implement effective corrective and preventive actions, and communicate their response to the FDA to demonstrate compliance and prevent future recurrences.