FDA Adverse Event
Malfunction
Summary report: N
CONMED CORPORATION
MDR report key: 294560
·
Received September 5, 2000
Report
- Report Number
- 1720159-2000-00070
- Event Type
- Malfunction
- Date Received
- September 5, 2000
- Date of Event
- August 7, 2000
- Report Date
- August 8, 2000
- Manufacturer
- CONMED/ASPEN LABS
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE TO REMOVE A GROWTH ON THE NECK, THERE WAS A FIRE WHICH BURNED THE PT'S MOUTH, CHEST, NECK AND SINGED HAIR ON THE LEFT SIDE. THE BURNS ARE NOT EXPECTED TO REQUIRE INTERVENTION. THE BURNS WERE PARTIAL THICKNESS. THERE WAS OXYGEN IN USE DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED CORPORATION | ELECTROSURGICAL UNIT | GEI | CONMED/ASPEN LABS | EXCALIBUR PLUS PC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | MEGADINE PENCIL & ELECTRODE, #0035H,| 3-M DISPERSIVE ELECTRODE, #1179C. |