FDA Adverse Event
Malfunction
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 1935684
·
Received December 16, 2010
Report
- Report Number
- 1717344-2010-00935
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- January 1, 2010
- Report Date
- December 3, 2010
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE GENERATOR WAS IN BIPOLAR MODE IT SELF-ACTIVATED. THERE WAS A GYRUS EVEREST HAND PIECE AND FOOT SWITCH INSERTED INTO THE UNIT. THE PT RECEIVED A MINOR INTERNAL BURN REPORTED AS BEING SUPERFICIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORCETRIAD ENERGY PLATFORM | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP (VALLEYLAB) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | GYRUS EVEREST HANDPIECE - LOT# UNK| (B)(4) FOOT SWITCH - LOT # 616153 |