FDA Adverse Event
Malfunction
Summary report: N
REPAIR TPS IRRIGATION CONSOLE
MDR report key: 1935158
·
Received December 6, 2010
Report
- Report Number
- 1811755-2010-01902
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- K942956
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CONSOLE WAS RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.
Description of Event or Problem · 1
IT WAS REPORTED THAT SMOKE WAS COMING OUT OF THE CONSOLE WHILE THE EQUIPMENT WAS BEING TESTED PRIOR TO THE START OF A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR TPS IRRIGATION CONSOLE | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | HWE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |