FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2035874
·
Received March 2, 2011
Report
- Report Number
- 1811755-2011-00656
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- September 17, 2010
- Report Date
- September 17, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE TECH REMOVED AND REPLACED THE WIRE HARNESS AND PUT THE UNIT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE FIELD SERVICE TECH THAT UPON INSPECTION, THE WIRE HARNESS HAD MELTED DOWN TO THE WIRE. 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 | AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |