Olympus Medical Systems Corporation Warning Letter Details

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.