FDA Adverse Event
Malfunction
Summary report: N
RFG-3C PLUS SYSTEM, 117V/60HZ
MDR report key: 1014066
·
Received March 13, 2008
Report
- Report Number
- 1717344-2008-00093
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 19, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GXD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE GENERATOR HAS BEEN RETURNED AND IS CURRENTLY BEING EVALUATED. WHEN THE INVESTIGATION IS DONE, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
THE REPORT STATED THAT DURING A RADIO FREQUENCY PAIN MANAGEMENT PROCEDURE, THE GENERATOR WAS SET FOR 70 DEGREES FOR 60 SECONDS BUT THE GENERATOR WOULD NOT REACH TEMPERATURE. THE PT WAS UNDER MILD SEDATION AND THE NEEDLE HAD BEEN INSERTED UP INTO THE TRIGEMINAL NERVE, AND REPEATED ATTEMPTS TO ACTIVATE IT FAILED. THEY HAD TO WITHDRAW THE NEEDLE, SEND THE PT TO THE PACU AND RESCHEDULE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RFG-3C PLUS SYSTEM, 117V/60HZ | RADIO FREQUENCY GENERATOR | GXD | COVIDIEN LP (VALLEYLAB) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |