FDA Adverse Event
Malfunction
Summary report: N
CAMERA "MAJ-554", VIDEO, HEAD, FOR OTV-SC, WITH FILTER
MDR report key: 23853741
·
Received December 19, 2025
Report
- Report Number
- 3002808148-2025-25960
- Event Type
- Malfunction
- Date Received
- December 19, 2025
- Report Date
- December 19, 2025
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K955404
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CAMERA HEAD HAD NO IMAGE AND LOOSE VIDEO ADAPTER. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2312065 | CAMERA "MAJ-554", VIDEO, HEAD, FOR OTV-SC, WITH FILTER | CAMERA HEAD | FET | SHIRAKAWA OLYMPUS CO., LTD. | A4899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |