FDA Adverse Event
Malfunction
Summary report: N
PKG, CROSSFIRE 2 CONSOLE
MDR report key: 17225027
·
Received June 29, 2023
Report
- Report Number
- 0002936485-2023-00643
- Event Type
- Malfunction
- Date Received
- June 29, 2023
- Date of Event
- June 9, 2023
- Report Date
- June 7, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GEI
- UDI-DI
- 07613327058109
- PMA / PMN Number
- K071859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: EIB, CHASE, REP, CONSOLE BEGAN SMOKING DURING CASE WHILE USING ABLATOR THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE ROOT CAUSE IS THE RF BOARD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263049 | PKG, CROSSFIRE 2 CONSOLE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY-SAN JOSE | 0475100000 | 07613327058109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |