FDA Adverse Event
Injury
Summary report: N
DYONICS RF SYSTEM
MDR report key: 2030697
·
Received March 18, 2011
Report
- Report Number
- 2951580-2011-00034
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K093165
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DATE OF PROCEDURE WAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED, THEREFORE, AN ESTIMATED MONTH AND YEAR WERE PROVIDED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A F/U REPORT WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2951580-2011-00039.
Description of Event or Problem · 1
DURING A PROCEDURE, USING A DYONICS RF SYSTEM AND A DYONICS RF-S WHIRLWIND 90 DEGREE PROBE WITH INTEGRATED CABLE, THE PT WAS REPORTED TO HAVE SUSTAINED A SECOND DEGREE BURN ON THE SHOULDER FROM HOT FLUID DRIPPING FROM THE CANNULA. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYONICS RF SYSTEM | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. | D01946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |