PENTAX
Report
- Report Number
- 9610877-2021-00786
- Event Type
- Malfunction
- Date Received
- September 14, 2021
- Date of Event
- August 16, 2021
- Report Date
- December 6, 2022
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FET
- PMA / PMN Number
- K934918
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVALUATION SUMMARY: BASED ON REPAIR INFORMATION, IT IS ASSUMED, THAT THE FAILURE OF THE PROCESSOR INFRASTRUCTURE MAY HAVE BEEN THE CAUSE OF THIS EVENT. CORRECTION INFORMATION: H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT.
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. SIMILAR MODEL EPK-1000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K934918. (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.
PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX LOANER VIDEO PROCESSOR EPK-1000. IN THE EVENT REPORTED, IT WAS STATED THAT THERE WAS NO VIDEO IMAGE, SCOPE CUTS OUT. THE EVENT TIMING IS UNKNOWN. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. THE LOANER DEVICE WAS RETURNED TO PENTAX MEDICAL SERVICE FACILITY ON SERVICE ORDER (B)(4) WHERE IT WAS EVALUATED, AND THE USER NARRATIVE WAS CONFIRMED. INSPECTION FINDINGS ARE AS FOLLOWS: PROCESS PCB NTSC HAD NO IMAGE. SINCE THIS WAS A PENTAX ASSET WHERE THE MAIN PCB FAILED, PENTAX DECIDED TO SCRAP THE DEVICE. SCRAP PENDING. NO OTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1364466 | PENTAX | VIDEO PROCESSOR (INTERNATIONAL) | FET | HOYA CORPORATION PENTAX TOKYO OFFICE | EPK-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |