Olympus Medical Systems CorporationSeptember 9, 2022

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

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Record Details

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.

Company: Olympus Medical Systems Corporation
Inspection Date: September 9, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Esteban Beltran

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ID · ae9bbd00-cda2-496b-8b7f-fb0767255b64