FDA Adverse Event
Injury
Summary report: N
CONMED CORPORATION
MDR report key: 239499
·
Received September 7, 1999
Report
- Report Number
- 1720159-1999-00105
- Event Type
- Injury
- Date Received
- September 7, 1999
- Date of Event
- August 4, 1999
- Report Date
- August 10, 1999
- Manufacturer
- ASPEN LABORATORIES, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING THORACOSURGERIES ONE OF THE TWO DRS PERFORMING THE SURGERY WOULD GET A DEEP PUNCTURE BURN TO THE FINGER. VARIOUS ELECTROSURGICAL PENCILS WERE USED AND THERE WERE NO SIGNS OF BURNING ON THEM. THERE WERE A TOTAL OF 18 EVENTS. THE FIRST EVENT WAS 1720159-1999-00088 AND THIS IS THE LAST EVENT.
Description of Event or Problem · 2
DURING THORACOSURGERIES ONE OF THE TWO DRS PERFORMING THE SURGERY WOULD GET A DEEP PUNCTURE BURN TO THE FINGER. VARIOUS ELECTROSURGICAL PENCILS WERE USED AND THERE WERE NO SIGNS OF BURNING ON THEM. THERE WERE A TOTAL OF 18 EVENTS. THE FIRST EVENT WAS 1720159-1999-00088 AND THIS IS THE LAST EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED CORPORATION | ELECTROSURGICAL UNIT | GEI | ASPEN LABORATORIES, INC. | EXCALIBUR PLUS PC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | ||
| 2 | 30 YR |