FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2477643
·
Received February 28, 2012
Report
- Report Number
- 1811755-2012-00676
- Event Type
- Malfunction
- Date Received
- February 28, 2012
- Date of Event
- February 6, 2012
- Report Date
- February 6, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE TECH WAS DISPATCHED TO THE USER FACILITY AND THE COMPLAINT WAS CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE CLEANING PROCESS, MELTING DAMAGE WAS OBSERVED ON THE ROVER POWER CORD. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGES WITH THIS EVENT.
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 |