PENTAX
Report
- Report Number
- 9610877-2021-51030
- Event Type
- Malfunction
- Date Received
- December 27, 2021
- Date of Event
- December 10, 2021
- Report Date
- December 27, 2021
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FAJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EB-1575K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131028. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE, AND THE CCD DRIVER PCB DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE, AND THE CCD DRIVER PCB. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EB-1575K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131028. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE, AND THE CCD DRIVER PCB DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE, AND THE CCD DRIVER PCB. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986854 | PENTAX | VIDEO CYSTOSCOPE 2.0C 5.5TP 400L | FAJ | HOYA CORPORATION PENTAX TOKYO OFFICE | ECY-1575K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |