FDA Adverse Event
Malfunction
Summary report: N
NEPTUNE 2 ROVER ULTRA (120V)
MDR report key: 2006104
·
Received February 22, 2011
Report
- Report Number
- 1811755-2011-00564
- Event Type
- Malfunction
- Date Received
- February 22, 2011
- Date of Event
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FYD
- PMA / PMN Number
- K012991
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS EVALUATED BY THE FIELD SVC REP. THE SMOKE EVACUATION FILTER NEEDED TO BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GYN PROCEDURE, THERE WAS SMOKE SEEN AT THE SMOKE EVACUATOR TUBING. THE UNIT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEPTUNE 2 ROVER ULTRA (120V) | AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO | FYD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |