FDA Adverse Event
Malfunction
Summary report: N
COOL-TIP RF SINGLE, 15 CMX 3 C
MDR report key: 1000537
·
Received February 11, 2008
Report
- Report Number
- 1717344-2008-00046
- Event Type
- Malfunction
- Date Received
- February 11, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 6, 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: 02/11/2008. THE INCIDENT SAMPLE WAS NOT RETURNED FOR EVALUATION THEREFORE AN EVALUATION COULD NOT BE PERFORMED. VALLEYLAB LABELING REGARDING THE SETUP OF THE COOL-TIP SYSTEM INCLUDES THE USE OF STERILE WATER WHICH PREVENTS UNINTENDED CONTAMINATION OF THE STERILE FIELD. CONTINUOUS IMPROVEMENTS TO TUBING SET DESIGN HAVE SIGNIFICANTLY REDUCED THE TREND IN LEAKAGE COMPLAINTS.
Description of Event or Problem · 1
THE REPORT STATED THAT PRIOR TO RADIO FREQUENCY ABLATION PROCEDURE, THE WATER CIRCULATION WAS CHECKED AND A LEAK WAS FOUND BETWEEN THE NEEDLE AND THE GRIP. ANOTHER NEEDLE ELECTRODE WAS OPENED AND USED. THERE WAS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL-TIP RF SINGLE, 15 CMX 3 C | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 107807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening |