FDA Adverse Event
Injury
Summary report: N
RIGHT ANGLE 90 DEGREE ICW
MDR report key: 2792177
·
Received October 11, 2012
Report
- Report Number
- 3006524618-2012-00817
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- September 14, 2012
- Report Date
- September 14, 2012
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K033584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDLE STARTED TO GET HOT AND SMOKE WAS COMING FROM THE CANNULA. NO PT OR USER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT ANGLE 90 DEGREE ICW | ELECTROSURGICAL, CUTTING & COAGULATION DE | GEI | ARTHROCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |