FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2132289
·
Received June 11, 2011
Report
- Report Number
- 1811755-2011-02114
- Event Type
- Malfunction
- Date Received
- June 11, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY A FIELD SERVICE REPRESENTATIVE. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS RECEIVED A REVIEWED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEPTUNE HAD AN EXPOSED WIRE. NO OTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. IT IS UNKNOWN IF THE PROTECTIVE INSULATION WAS INTACT.
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 |