FDA Adverse Event
Other
Summary report: N
2.3MM 25 DEGREE SHORT BEVEL
MDR report key: 2011907
·
Received February 28, 2011
Report
- Report Number
- 2951580-2011-00023
- Event Type
- Other
- Date Received
- February 28, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 28, 2011
- Manufacturer
- ARTHROCARE CORP
- Product Code
- GEI
- PMA / PMN Number
- K083306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PT INFO WAS REQUESTED, BUT PHYSICIAN DID NOT PROVIDE IT TO ARTHROCARE. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE PROVIDED WITH THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 1
A CLINICAL INCIDENT INVOLVING A 2.3MM 25 DEGREE SHORT BEVEL ARTHROWAND WAS REPORTED TO ARTHROCARE. REPORTEDLY THE ARTHROWAND FAILED TO ABLATE THE PT'S TISSUE, RESULTING IN AN HOUR DELAY IN SURGERY. THERE WAS NO REPORTED INJURY TO THE PT. NO OTHER INFO WAS PROVIDED FOR THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.3MM 25 DEGREE SHORT BEVEL | ELECTOSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP | 2019780-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |