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

Olympus Medical Systems Corporation, a specification developer in Hachioji-shi, Tokyo, was cited for failing to submit Medical Device Reports (MDRs) within the required 30-day timeframe. The inspection revealed 37 late MDR submissions for its Cysto-Nephro Scope and Uretero-Reno Scope product families. This issue is a recurring observation, indicating a persistent problem with timely reporting of adverse events.