FDA Adverse Event
Injury
Summary report: N
EVAC 70 XTRA WITH INTEGRATED CABLE
MDR report key: 1720175
·
Received June 9, 2010
Report
- Report Number
- 2951580-2010-00055
- Event Type
- Injury
- Date Received
- June 9, 2010
- Date of Event
- May 13, 2010
- Report Date
- June 9, 2010
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K070374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. THE SECOND DEVICE, COBLATOR II CONTROLLER, USED IN THE SAME PROCEDURE IS REPORTED UNDER MEDWATCH NUMBER 2951580-2010-00056.
Description of Event or Problem · 1
DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE USING AN EVAC 70 XTRA WITH INTEGRATED CABLE ARTHROCARE WAND AND COBLATOR II CONTROLLER, THE PATIENT REPORTEDLY SUSTAINED A 1.5 MM BURN TO INSIDE LEFT HAND SIDE TO THE MUCOSA RESULTING IN A BLISTER. THE BURN WAS TREATED WITH OINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVAC 70 XTRA WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORPORATION | B229290-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Other |