FDA Adverse Event
Summary report: N
CONMED
MDR report key: 3031277
·
Received April 4, 2006
Report
- Report Number
- 3031277
- Date Received
- April 4, 2006
- Date of Event
- February 15, 2006
- Report Date
- February 27, 2006
- Manufacturer
- CONMED
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGERY PHYSICIAN NOTED BOVIE HANDLE TO BE HOT; SHORTLY THEREAFTER A LAP SPONGE WAS SCORCHED. BOVIE HANDLE WAS REMOVED FROM SERVICE AND A NEW ONE WAS USED WITHOUT ANY FURTHER PROBLEMS. FOLLOWING THE CASE THE PATIENT WAS FOUND TO HAVE AN APPROXIMATELY 1 INCH FIRST DEGREE "STREAK BURN" BELOW THE INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED | CAUTERY UNIT | GEI | CONMED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |