FDA Adverse Event
Malfunction
Summary report: N
SURGISTOOL
MDR report key: 1981682
·
Received January 12, 2011
Report
- Report Number
- 1831750-2011-00301
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT BRAKE TIP IS MISSING AND THE BRAKE PEDAL IS BROKEN. NO PATIENT INVOLVEMENT OR 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 | 0830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |