FDA Adverse Event
Malfunction
Summary report: N
CONMED CORPORATION
MDR report key: 500304
·
Received December 2, 2003
Report
- Report Number
- 1720159-2003-00119
- Event Type
- Malfunction
- Date Received
- December 2, 2003
- Date of Event
- September 1, 2003
- Report Date
- November 4, 2003
- Manufacturer
- CONMED ELECTROSURGERY
- 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
THE UNIT ACTIVATED ON ITS OWN. THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED CORPORATION | ELECTROSURGICAL UNIT | GEI | CONMED ELECTROSURGERY | EXCALIBUR PLUS PC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LAPARASCOPIC GUIDANT VEIN HARVES SCISSORS| MANUFACTURER UNK. |