FDA Adverse Event
Malfunction
Summary report: N
CONMED CORPORATION
MDR report key: 218836
·
Received April 8, 1999
Report
- Report Number
- 1720159-1999-00010
- Event Type
- Malfunction
- Date Received
- April 8, 1999
- Date of Event
- February 1, 1999
- Report Date
- March 11, 1999
- Manufacturer
- ASPEN LABORATORIES, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A UROLOGY OPERATION THERE WAS A PHYSICIAN BURN REPORTED. THIS BURN WAS NOT SERIOUS.
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 | NA |