FDA Adverse Event
Malfunction
Summary report: N
REPAIR NEPTUNE 2 ROVER
MDR report key: 1960836
·
Received December 17, 2010
Report
- Report Number
- 1811755-2010-02080
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY A FIELD SERVICE REP AND IT WAS FOUND THAT THE CAPACITOR HAD BURST AND RELEASED WAX. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE AT THE ACCOUNT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE ACCOUNT HEARD A POP FOLLOWED BY SMOKE COMING OUT OF THE NEPTUNE ROVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT AND THE INVESTIGATION IS ONGOING. THERE WERE NO REPORTED ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR NEPTUNE 2 ROVER | AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |