FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE 2 ROVER ULTRA (120V)
MDR report key: 2891083
·
Received November 14, 2012
Report
- Report Number
- 1811755-2012-04050
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A MANUFACTURER FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION CONFIRMED A BENT PIN ON THE POWER PLUG ASSEMBLY. THE CAUSE OF THE DAMAGE IS UNK, BUT MAY BE THE RESULT OF MISHANDLING. THE ROVER WAS REPAIRED AND RETURNED TO USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ROVER POWER CORD WAS HEATING UP. NO FURTHER INFO WAS PROVIDED BY THE USER FACILITY. NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE 2 ROVER ULTRA (120V) | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |