FDA Adverse Event
Malfunction
Summary report: N
SURGISTOOL
MDR report key: 2421771
·
Received January 16, 2012
Report
- Report Number
- 1831750-2012-00456
- Event Type
- Malfunction
- Date Received
- January 16, 2012
- Date of Event
- December 19, 2011
- Report Date
- December 19, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE JACK WAS DRIFTING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGISTOOL | STOLL, OPERATING ROOM | FZM | STRYKER MEDICAL | 0830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |