FDA Adverse Event
Malfunction
Summary report: N
COOL-TIP RF SYS 100V ENG
MDR report key: 1033031
·
Received April 22, 2008
Report
- Report Number
- 1717344-2008-00164
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 21, 2008
- Report Date
- March 25, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 04/22/2008. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. INTN'A AFFILIATE HAS BEEN ASKED IF THE GENERATOR IS BEING RETURNED FOR EVAL/ SERVICE. IF THE SAMPLE IS RECEIVED FOR EVAL/ SERVICE OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORT STATED THAT UPON TURNING ON THE RADIO FREQUENCY ABLATION GENERATOR, "IMP TEST FAILED" WAS DISPLAYED. THE GENERATOR WOULD NOT ACTIVATE. ANOTHER GENERATOR WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL-TIP RF SYS 100V ENG | RF ABLATION GENERATOR | GEI | COVIDIEN LP (VALLEYLAB) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |