FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2233184
·
Received July 22, 2011
Report
- Report Number
- 1811755-2011-02648
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE REP INFORMED THE CUSTOMER THAT THE DEVICE FAILED PT LEAKAGE TEST AND COULD NOT BE RETURNED TO SERVICE UNTIL REPAIRED. THE CUSTOMER DECLINED REPAIR STATING THAT THEY WERE PURCHASING A NEW UNIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE ON THE UNIT IF FAILED ELECTRICAL SAFETY TEST FOR EXCESSIVE PT LEAKAGE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO 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 |