FDA Adverse Event
Malfunction
Summary report: N
COOL-TIP RF SYS 100V ENG
MDR report key: 1163296
·
Received September 9, 2008
Report
- Report Number
- 1717344-2008-00419
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 18, 2008
- Manufacturer
- COVIDIEN LP, VALLEYLAB
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 09/09/2008. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D 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 STATES THAT DURING A RADIOFREQUENCY ABLATION, THE MESSAGE "RF INTERRUPTED PRESS TIMER RESET" APPEARED IN GENERATOR MESSAGE WINDOW. THE GENERATOR WAS REBOOTED TWICE, BUT NOTHING CHANGED AND NO POWER WAS DELIVERED. THE DR ALSO TRIED REPLACING THE NEEDLE TWICE, BUT THE PROCEDURE HAD TO BE ABORTED.
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 | 69 YR |