FDA Adverse Event
Malfunction
Summary report: N
HD CAMERA HEAD
MDR report key: 24039112
·
Received January 12, 2026
Report
- Report Number
- 3002808148-2026-00987
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 15, 2025
- Report Date
- April 3, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K102059
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO A PREVIOUSLY SUBMITTED REPORT. THIS EVENT WAS REPORTED AS A DUPLICATE REPORT. PLEASE REFER TO MFG REPORT 3002808148-2026-00939-00. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CAMERA HEAD SHOWED A BAD IMAGE AND HAD A BROKEN LENS. THIS ISSUE WAS FOUND DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96138 | HD CAMERA HEAD | AUTOCLAVABLE CAMERA HEAD | FET | SHIRAKAWA OLYMPUS CO., LTD. | CH-S190-08-LB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |