FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2076178
·
Received March 31, 2011
Report
- Report Number
- 1811755-2011-01079
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE TECH REMOVED AND REPLACED THE POWER CORD. THE UNIT PASSED ALL SAFETY TESTS AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
THE FIELD SERVICE TECH REPORTED THAT THE NEPTUNE ROVER'S POWER CORD HAD EXPOSED WIRES AND THE PLUG WAS MELTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |