FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
MDR report key: 2472754
·
Received February 23, 2012
Report
- Report Number
- 1811755-2012-00637
- Event Type
- Malfunction
- Date Received
- February 23, 2012
- Date of Event
- January 26, 2012
- Report Date
- January 26, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A MFR FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION CONFIRMED THAT THE POWER CORD WAS SHREDDED, HOWEVER, NO SPARKS WERE OBSERVED. THE CAUSE OF THE CORD DAMAGE IS UNK, BUT MAY BE THE RESULT OF MISHANDLING. THE POWER CORD ASSEMBLY WAS REPLACED AND THE ROVER RETURNED TO USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT SPARKS FROM A DAMAGED ROVER POWER CORD WAS OBSERVED. THERE WERE NO REPORTS OF ANY INJURIES ASSOCIATED WITH THIS EVENT. NO FURTHER INFO WAS PROVIDED FROM THE USER FACILITY AND ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.
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 |