FDA Adverse Event
Malfunction
Summary report: N
PKG, CROSSFIRE 2 CONSOLE
MDR report key: 17490831
·
Received August 9, 2023
Report
- Report Number
- 0002936485-2023-00786
- Event Type
- Malfunction
- Date Received
- August 9, 2023
- Date of Event
- July 17, 2023
- Report Date
- August 29, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GEI
- PMA / PMN Number
- K071859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: EIB, IVANA, SM REP, SPARK AND SMOKE WHEN THE SERFAS 90S CRUISE WAS ENGAGED. PO# TEMP THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE ROOT CAUSE IS THE POWER BOARD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT AND SPARKING.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT AND SPARKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099851 | PKG, CROSSFIRE 2 CONSOLE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |