FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
Report
- Report Number
- 0002936485-2025-00164
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 17, 2025
- Report Date
- June 10, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OWN
- UDI-DI
- 07613327462760
- PMA / PMN Number
- K192292
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
UPDATED G4 PMA/510(K) TO K192292. UPDATED H6 MEDICAL DEVICE PROBLEM TO OVERHEATING OF DEVICE. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE FOR EVALUATION, AND IT IS YET TO BE RECEIVED IN-HOUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: TOO MUCH HEAT. PROBABLE ROOT CAUSE: REED SWITCH ASSEMBLY MALFUNCTION USE ERROR. THE DEVICE MANUFACTURER DATE IS NOT KNOWN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2630413 | FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM | CONFOCAL OPTICAL IMAGING | OWN | STRYKER ENDOSCOPY-SAN JOSE | 07613327462760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |