FDA Adverse Event
Malfunction
Summary report: N
SURGISTOOL
MDR report key: 1902481
·
Received November 12, 2010
Report
- Report Number
- 1831750-2010-03696
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 12, 2010
- Report Date
- October 12, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- 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 THROUGH A SERVICE REPORT THAT THE BRAKES WERE NOT OPERATING. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGISTOOL | STOOL-OPERATING ROOM | FZM | STRYKER CORP., MEDICAL DIV. | 0830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |