FDA Adverse Event
Malfunction
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 4235103
·
Received September 5, 2014
Report
- Report Number
- 1717344-2014-00765
- Event Type
- Malfunction
- Date Received
- September 5, 2014
- Report Date
- August 26, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND THE INVESTIGATION CONFIRMED THE CUSTOMER'S REPORT OF REM COMES ON WITH NO RETURN CABLE. THE FAILURE WAS ISOLATED TO THE RF BOARD. THE RF BOARD WAS REPLACED TO CORRECT THE FAILURE. THE GENERATOR WAS CALIBRATED. THOROUGHLY TESTED AND WAS FOUND TO MEET ALL SPECIFICATIONS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE REM COMES ON WITH NO RETURN CABLE. INITIAL EVALUATION OF THE RETURNED DEVICE FOUND THE REM CIRCUIT WAS ACTIVE WITH NO CABLE INSERTED INTO THE REM RECEPTACLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543579 | FORCETRIAD ENERGY PLATFORM | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |