FDA Adverse Event
Other
Summary report: N
VULCAN GENERATOR
MDR report key: 1213887
·
Received October 27, 2008
Report
- Report Number
- 1643264-2008-00022
- Event Type
- Other
- Date Received
- October 27, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 16, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GENERATOR WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
AFTER A RIGHT KNEE ARTHROSCOPY, THE PATIENT WAS IN THE RECOVERY ROOM AND A SMALL BURN WAS NOTICED ON THE INNER RIGHT AND LEFT THIGH. A CONMED SPLIT PAD WAS PLACED ON THE LEFT THIGH. THIS UNIT WAS UPGRADED TO V3.71 SIX WEEKS AGO AND SINCE THEN EXPERIENCING INTERMITTENT THERMAL WARNING ERROR MESSAGES WHICH WOULD GO AWAY AFTER REBOOTING. THERE IS NO INFORMATION ON THE PROBE THAT WAS USED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VULCAN GENERATOR | VULCAN GENERATOR | GEI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7209673 | S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |