FDA Adverse Event
Malfunction
Summary report: N
FORCE FX-8C GENERATOR (SHANGHAI)
MDR report key: 3082503
·
Received April 17, 2013
Report
- Report Number
- 3006451981-2013-00088
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Report Date
- March 22, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION OF THE RETURNED EQUIPMENT DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE GENERATOR WAS MAKING A LOUD NOISE WHEN IN CONTACT WITH TISSUE. THE UNIT WAS LATER TESTED WITH AN ANALYZER ALONG WITH A HANDPIECE AND REM PAD CONNECTED TO THE TEST PORT. A LITTLE FLAME WAS OBSERVED AT THE TIP OF THE HANDPIECE WHEN THE UNIT WAS TURNED ON. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165496 | FORCE FX-8C GENERATOR (SHANGHAI) | ELECTROSURGICLA GENERATOR | GEI | COVIDIEN LLC (SHANGHAI) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | UNK HANDPIECE| UNK REM PAD |