FDA Adverse Event
Malfunction
Summary report: N
HD 3CMOS AUTOCLAVABLE CAMERA HEAD
MDR report key: 23617238
·
Received November 21, 2025
Report
- Report Number
- 3002808148-2025-23062
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 29, 2025
- Report Date
- December 11, 2025
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FET
- PMA / PMN Number
- K200542
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
Additional Manufacturer Narrative · 0
B5 CORRECTION: 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 # 3002808148-2025-18739-00.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD HAD A BLURRY IMAGE, WAS NOT PRODUCING PICTURES AND THE CAMERA HEAD WAS NOT WORKING. THERE WERE NO REPORTS OF PATIENT HARM.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2303662 | HD 3CMOS AUTOCLAVABLE CAMERA HEAD | AUTOCLAVABLE CAMERA HEAD | FET | SHIRAKAWA OLYMPUS CO., LTD. | CH-S200-XZ-EA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |