PENTAX
Report
- Report Number
- 9610877-2021-50869
- Event Type
- Malfunction
- Date Received
- December 20, 2021
- Date of Event
- December 14, 2021
- Report Date
- December 20, 2021
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDF
- 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 EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. WE CHECKED THE RETURNED UNIT AND CONFIRMED THE CCDMODULE AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. 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 EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. WE CHECKED THE RETURNED UNIT AND CONFIRMED THE CCDMODULE AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. 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 |
|---|---|---|---|---|---|---|---|
| 1941522 | PENTAX | VIDEO COLONOSCOPE | FDF | HOYA CORPORATION PENTAX TOKYO OFFICE | EC38-I10NL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |