FDA Adverse Event
Malfunction
Summary report: N
PKG, CROSSFIRE 2 CONSOLE
MDR report key: 17083490
·
Received June 7, 2023
Report
- Report Number
- 0002936485-2023-00563
- Event Type
- Malfunction
- Date Received
- June 7, 2023
- Date of Event
- March 23, 2023
- Report Date
- June 7, 2023
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GEI
- UDI-DI
- 07613327058109
- PMA / PMN Number
- K071859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: EIB, KAYLA, CUSTOMER, DOES NOT WORK WITH FOOTPEDAL OR SHAVER, PO# TEMP THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE/S COULD BE THE RECEPTACLE BOARD, FRONT BOARD, SHAVER, OR FOOTSWITCH. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE RE-OCCURRENCE.
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 |
|---|---|---|---|---|---|---|---|
| 1011262 | PKG, CROSSFIRE 2 CONSOLE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY-SAN JOSE | 0475100000 | 07613327058109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |