483
Olympus Medical Systems CorporationOlympus Medical Systems Corporation – FDA 483, Nov 21, 2025
Record Details
Olympus Medical Systems Corporation, a medical device specification developer in Hachioji-shi, Tokyo, Japan, was cited for significant deficiencies in its quality system. The inspection revealed inadequate corrective and preventive action procedures, incomplete risk analysis, and unestablished design control procedures. These issues were linked to serious patient safety concerns, including patient death due to device fire and retention of charred device remnants in patients.
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