FDA Adverse Event
Summary report: N
VALLEYLAB FORCE TRIAD
MDR report key: 2875083
·
Received November 12, 2012
Report
- Report Number
- 2875083
- Date Received
- November 12, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 29, 2012
- Manufacturer
- COVIDIEN KENDALL
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE ESU WAS INVOLVED IN AN INCIDENT WHERE DURING AN ADENOTONSILLECTOMY, OR STAFF NOTICED A SMALL BURN, ABOUT 0.25" IN DIAMETER, ON THE RIGHT CREASE OF THE MOUTH, EXTERNAL. THE REM (RETURN ELECTRODE MONITORING) PAD WAS ATTACHED TO THE CHEST OF THE PATIENT. SETTINGS OF THE DEVICE AT THE TIME OF THE INCIDENT IS UNKNOWN. IT IS ALSO UNKNOWN WHAT CUT OR COAG SETTING THE DEVICE WAS IN, OTHER THAN USING "MONO-POLAR" MODE. A DISPOSABLE PENCIL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALLEYLAB FORCE TRIAD | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | COVIDIEN KENDALL | * | 1057037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |