FDA Adverse Event
Summary report: N
FORCE FXC
MDR report key: 1052408
·
Received March 27, 2008
Report
- Report Number
- 1052408
- Date Received
- March 27, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 27, 2008
- Manufacturer
- COVIDIEN VALLEYLAB
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
DOCTOR REPORTS THAT HE/SHE FELT A TWINGE IN HAND THAT WAS HOLDING THE HEMOSTAT DURING COAGULATION WITH AN ELECTROSURGICAL UNIT. UNIT AND ALL DISPOSABLES WERE BOUGHT TO BIOMED AND TESTED. ELECTRICAL SAFETY TEST AND OUTPUT READINGS ON ALL LEVELS WERE CONSISTENT WITH PAST READINGS AND FALL WITHIN ACCEPTED LEVELS. BIOMED WAS NOT ABLE TO DUPLICATE PROBLEM AS REPORTED. UNIT WAS RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORCE FXC | ESU | GEI | COVIDIEN VALLEYLAB | FORCE FXC | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES| NO OTHER THERAPIES |