# Olympus Medical Systems Corporation – FDA 483, Nov 21, 2025

Source: https://www.keypedia.com/records/483/olympus-medical-systems-corporation/0eecfb1a-6a01-49dc-aa9b-321809a7049e

> FDA 483 for Olympus Medical Systems Corporation on November 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olympus Medical Systems Corporation
- Inspection Date: 2025-11-21
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2022-09-09](https://www.keypedia.com/records/warning_letter/olympus-medical-systems-corporation/d550110d-d64f-4e50-a9f0-9789112f6ab5) — date: September 9, 2022
- [483 - 2022-09-09](https://www.keypedia.com/records/483/olympus-medical-systems-corporation/ae9bbd00-cda2-496b-8b7f-fb0767255b64) — date: September 9, 2022
- [WARNING_LETTER](https://www.keypedia.com/records/warning_letter/olympus-medical-systems-corporation/379fd9bd-61c8-414d-b11c-b129dea1aa8b)

## Related Officers

- [Rebecca E. Dorsey](https://www.keypedia.com/people/rebecca-e-dorsey/a52b659a-4a80-47fd-bc62-516daea4efd7)
- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/olympus-medical-systems-corporation/85e505c8-f012-4c6c-bce6-67e3879f0d01

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8