FDA Adverse Event
Malfunction
Summary report: N
SURGISTOOL
MDR report key: 1941121
·
Received December 8, 2010
Report
- Report Number
- 1831750-2010-04616
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- FZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HYDRAULIC JACK IS LEAKING OIL. IT IS UNK IF THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGISTOOL | STOOL, OPERATING-ROOM | FZM | STRYKER CORP, MEDICAL DIVISION | 0830000000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |