FDA Adverse Event
Other
Summary report: N
COVATOR 20 WITH INTEGRATED CABLE ARTHROWAND
MDR report key: 2011836
·
Received February 24, 2011
Report
- Report Number
- 2951580-2011-00019
- Event Type
- Other
- Date Received
- February 24, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 24, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K083306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE PROVIDED ONCE THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED.
Description of Event or Problem · 1
DURING A LABRUM REPAIR PROCEDURE USING A COVATOR 20 WITH INTEGRATED CABLE ARTHROWAND, A SMALL PIECE OF PLASTIC BROKE OFF THE ARTHROWAND. REPORTEDLY THE FRAGMENT WAS NOT FOUND OR REMOVED FROM THE PT. IT IS NOT KNOWN IF THE FRAGMENT REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COVATOR 20 WITH INTEGRATED CABLE ARTHROWAND | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. | C432380-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |