PKG CROSSFIRE 2 CONSOLE
Report
- Report Number
- 0002936485-2025-00699
- Event Type
- Malfunction
- Date Received
- August 15, 2025
- Date of Event
- July 11, 2025
- Report Date
- October 16, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GEI
- UDI-DI
- 07613327058109
- PMA / PMN Number
- K071859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
- Health Professional
- N
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.
THREE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE FOR EVALUATION, AND IT IS YET TO BE RECEIVED IN-HOUSE. NO FURTHER ATTEMPTS TO RETRIEVE THE DEVICE ARE REQUIRED. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: PNR - NO FUNCTION PROBABLE ROOT CAUSE: HARDWARE FAILURE SOFTWARE ERROR DUE TO HARDWARE FAILURE DAMAGED RECEPTACLE BOARD DAMAGED POWER BOARD FRONT BOARD FAILURE LOOSE FLEX CABLE DAMAGE TO CONSOLE DURING SHIPPING/ HANDLING ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE INSUFFICIENT CYBERSECURITY (CF) THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THERE WAS NO FUNCTION.
IT WAS REPORTED THAT THERE WAS NO FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1180046 | PKG CROSSFIRE 2 CONSOLE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY-SAN JOSE | 07613327058109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |