FDA Adverse Event
Malfunction
Summary report: N
COOL-TIP RF SYS 100V ENG
MDR report key: 1012773
·
Received March 12, 2008
Report
- Report Number
- 1717344-2008-00075
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 13, 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
THE UNIT WAS RETURNED TO OUR SERVICE CENTER. THEY WERE UNABLE TO DUPLICATE THE REPORTED ISSUE. HOWEVER THEY DID FIND THE IMPEDANCE UNSTABLE AND RE-CALIBRATED THE UNIT.
Description of Event or Problem · 1
THE REPORT STATED THAT TWO MINUTES INTO THE RADIO FREQUENCY ABLATION PROCEDURE THE GENERATOR STOPPED WORKING. POWER CYCLING THE GENERATOR, IT STARTED BACK UP BUT THEN TWO MINUTES LATER IT AGAIN SHUT DOWN. THE UNIT AGAIN WAS POWER CYCLED AND AGAIN WORKED FOR TWO MINUTES. THIS WAS CONTINUED UNTIL THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PT INJURY INVOLVED.
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 | NEEDLE ELECTRODE LOT NUMBER UNK| ACT1520 |