FDA Adverse Event
Other
Summary report: N
COBLATOR II SYSTEM
MDR report key: 1080072
·
Received July 17, 2008
Report
- Report Number
- 2951580-2008-00053
- Event Type
- Other
- Date Received
- July 17, 2008
- Date of Event
- June 1, 2008
- Report Date
- July 16, 2008
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K030108
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CONTROLLER HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED. TWO DEVICES, COBLATOR II CONTROLLER AND THE COBLATOR II PLASMA WAND, WERE USED IN THE SAME PROCEDURE. THE SECOND DEVICE, COBLATOR II WAND, WILL BE FILED UNDER MDR 2951580-2008-00058.
Description of Event or Problem · 1
IN 2008, A CLINICAL INCIDENT INVOLVING A COBLATOR II CONTROLLER WAS REPORTED TO ARTHROCARE CORP. TWO DAYS FOLLOWING A TONSILLECTOMY PROCEDURE, THE PT HAD A SECONDARY REBLEED, WHICH REQUIRED ADMITTANCE TO HOSPITAL FOR TREATMENT. THE PT REQUIRED A BLOOD TRANSFUSION AND WAS ADMITTED TO THE ITU FOR 24 HOURS. IT WAS REPORTED THE PT HAS REHEALED AND IS REPORTED TO RECOVERING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBLATOR II SYSTEM | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | ARTHROCARE CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |