FDA Adverse Event
Malfunction
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 2221489
·
Received August 17, 2011
Report
- Report Number
- 1717344-2011-00695
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 4, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT GENERATOR HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE UNIT EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PT WAS BURNED BY AN UNK TYPE OF BIPOLAR HANDPIECE WHICH WAS LAID ON THE PT AND SELF-ACTIVATED. THE BURNS WERE DESCRIBED AS BEING 1ST AND 2ND DEGREE. THE 1ST DEGREE BURN WAS TREATED WITH VASELINE GAUZE AND THE 2ND DEGREE BURN WAS TREATED BY CLOSURE.
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 | 64 YR | UNKNOWN TYPE OF BIPOLAR HANDPIECE - LOT # UNK |