FDA Adverse Event
Malfunction
Summary report: N
COBLATOR II SURGERY SYSTEM
MDR report key: 2833870
·
Received November 5, 2012
Report
- Report Number
- 3006524618-2012-00865
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Date of Event
- September 25, 2012
- Report Date
- October 9, 2012
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K030108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE UNITED STATES. AS A RESULT OF FOREIGN CONFIDENTIALITY REQUIREMENTS AND INTERNATIONAL PRIVACY LAWS, NO PT INFO WAS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE COBLATOR II CONTROLLER SYSTEM BEGAN TO SMOKE. THIS CAUSED THE PROCEDURE TO BE INTERRUPTED AND RESULTED IN A DELAY OF OVER 30 MINUTES, AS THEY HAD TO DISCONNECT POWER TO THE CONTROLLER. THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED BIPOLAR ELECTROSURGICAL DEVICE. WE ARE AWAITING CLARIFICATION OF THE INCIDENT FROM THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBLATOR II SURGERY SYSTEM | ELECTROSURGICAL CUTTING AND COAGULATION DE | GEI | ARTHROCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |