FDA Adverse Event
Malfunction
Summary report: N
COBLATOR II (120V)
MDR report key: 3050387
·
Received April 8, 2013
Report
- Report Number
- 3006524618-2013-00142
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 12, 2013
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K032504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT 7-12 DAYS AFTER A TONSILLECTOMY PROCEDURE USING THE EVAC 70 XTRA WITH THE COBLATOR II SURGERY SYSTEM, THE PT EXPERIENCED A POST OPERATIVE RE-BLEED. NO INFO WAS PROVIDED TO INDICATE THE CONTROLLER SETTINGS AT THE TIME OF USE OR IF THERE WERE COAGULATION ISSUES WITH THE WAND, THEREFORE, THE FACILITY IS UNSURE IF THIS ISSUE IS ATTRIBUTED TO THE WAND OR THE CONTROLLER. NO FURTHER INFO WAS PROVIDED CONCERNING THE TREATMENT FOR THE RE-BLEED, HOWEVER, NO OTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144546 | COBLATOR II (120V) | OPERATOR CONSOLE, DIATHERMY UNIT | GEI | ARTHROCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Other |