FDA Adverse Event
Malfunction
Summary report: N
OLSEN
MDR report key: 138709
·
Received December 9, 1997
Report
- Report Number
- 2916288-1997-00008
- Event Type
- Malfunction
- Date Received
- December 9, 1997
- Report Date
- December 5, 1997
- Manufacturer
- OLSEN ELECTROSURGICAL, INC.
- Product Code
- GEI
- Removal / Correction Number
- RGA #2005
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A SURGERY, THE DOCTOR WAS SHOCKED TWICE BY THE DEVICE. THE SHOCK WAS PRECIPATED BY A GAP BETWEEN THE DEVICE INSULATION AND THE CABLE HOUSING AT THE DEVICE/CABLE JUNCTION. THE DOCTOR NOTED THE GAP BEFORE USE AND STILL ATTEMPTED USE AGAINST THE RECOMMENDATION OF THE CHARGE NURSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLSEN | MONOPOLAR CABLE | GEI | OLSEN ELECTROSURGICAL, INC. | 6-B | 019600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |