Olympus Medical Systems Corporation

Warning LetterOpen

Tomohisa Sakurai President Olympus Medical Systems Corporation 2951, Ishikawa-cho Hachioji-shi , Tokyo 192-8507 JapanFEI 3002807795Issued Dec 12, 2022Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002807795.

Violations2

Issue DateDec 12, 2022

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Olympus Medical Systems Corporation
Location: Tomohisa Sakurai President Olympus Medical Systems Corporation 2951, Ishikawa-cho Hachioji-shi , Tokyo 192-8507 Japan
FEI Number: 3002807795
Country: Japan
Issue Date: December 12, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Olympus Medical Systems Corporation manufactured gastrointestinal and surgical endoscopes that were found to be misbranded due to failures in Medical Device Reporting (MDR) compliance under 21 CFR Part 803. The company failed to submit required reports to FDA within 30 calendar days of becoming aware of device malfunctions, including specific incidents involving Uretero-Reno Fiberscope and Uretero-Reno Videoscope breakage or rupture that could cause or contribute to serious injury or death if recurrence occurred. An FDA inspection conducted in September 2022 at the company's Tokyo, Japan facility identified these violations, and the firm's response to the inspection findings was deemed inadequate.

Olympus Medical Systems Corporation FDA Warning Letter, December 12, 2022