PKG PRECISION LED LIGHT SOURCE
Report
- Report Number
- 0002936485-2025-00063
- Event Type
- Malfunction
- Date Received
- January 28, 2025
- Date of Event
- January 16, 2025
- Report Date
- May 22, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- FCW
- UDI-DI
- 07613327051322
- PMA / PMN Number
- K082813
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 117
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION AT STRYKER ENDOSCOPY BECAUSE IT WAS REPAIRED LOCALLY IN STRYKER FRANCE THE TECHNICAL SERVICE REPORT INDICATES: FAULT : ERROR MESSAGE E2 AND BLUE LIGHT REPAIR LEVEL : 1 ACTION TAKEN : REPLACE LED MODULE REPLACE ACTUATOR TESTS : FUNCTION TEST CALIBRATION GENERAL INSPECTIONS QIP" PROBABLE ROOT CAUSE: FRONT BOARD MALFUNCTION TOUCH SCREEN MALFUNCTION MAIN BOARD MALFUNCTION POWER SUPPLY MALFUNCTION AC INLET BOARD MALFUNCTION POWER BUTTON ROD DAMAGED INADEQUATE AIR FLOW SIDNE PORT MALFUNCTION POOR WORKMANSHIP USE ERRORS ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1441493 | PKG PRECISION LED LIGHT SOURCE | LIGHT SOURCE, FIBEROPTIC, ROUTINE | FCW | STRYKER ENDOSCOPY-SAN JOSE | 07613327051322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |