FDA Adverse Event
Other
Summary report: N
ULTRAVAC 90 WITH INTEGRATED CABLE
MDR report key: 2214017
·
Received August 3, 2011
Report
- Report Number
- 2951580-2011-00103
- Event Type
- Other
- Date Received
- August 3, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K033584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT INFO WAS REQUESTED BUT NOT PROVIDED. DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE LOT NUMBER WAS PROVIDED, AND THEREFORE A BATCH RECORD REVIEW WILL BE PERFORMED AND PROVIDED IN A FOLLOW UP REPORT. THE SECOND DEVICE USED IN THE SAME PROCEDURE WILL BE REPORTED IN MEDWATCH #2951580-2011-00104.
Description of Event or Problem · 1
DURING A SHOULDER ARTHROSCOPY TWO ULTRAVAC ARTHROWANDS WERE REPORTED AS BREAKING WERE THE SHAFT AND HAND PIECE MEET. THIS CAUSED AN EXTENDED SURGERY OF OVER 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ULTRAVAC ARTHROWAND. THERE WAS NO REPORTED ADVERSE EFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAVAC 90 WITH INTEGRATED CABLE | ELECTROSURGICAL, CUTTING & COAGULATION | GEI | ARTHROCARE CORPORATION | JG14110-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |