FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE 2 ROVER ULTRA (120V)
MDR report key: 2140378
·
Received June 17, 2011
Report
- Report Number
- 1811755-2011-02180
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 19, 2011
- Report Date
- May 19, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN. THE REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEPTUNE SMOKE WAS COMING FROM THE NEPTUNE DURING A PROCEDURE. ANOTHER NEPTUNE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
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 |