FDA Adverse Event
Malfunction
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 3941453
·
Received April 16, 2014
Report
- Report Number
- 1717344-2014-00322
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 21, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BIPOLAR ACTIVATED ON IT'S OWN. THERE WAS NO PT OR STAFF INJURY. PROCEDURE WAS NOT AVAILABLE. THE FOLLOWING PRODUCTS WERE IN USE AT THE TIME: LF1537, A WOLF HANDPIECE (TYPE UNK), AND AN E6019 BIPOLAR FOOTSWITCH. THE FOOTSWITCH IS NOT RETURNING FOR INVESTIGATION. THE BIOMED INDICATED THAT THE UNIT WAS SET TO AUTO-BIPOLAR MODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232209 | FORCETRIAD ENERGY PLATFORM | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | WOLF HANDPIECE, LOT #UNK| GEM BIPOLAR FOORSWITCH, E6019, LOT #UNK| NEW LIGASURE 5MM, LF1537, LOT #UNK |