BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SINGLE, 20 CMX 3 C

    MDR report key: 1051928 · Received May 23, 2008

    Report

    Report Number
    1717344-2008-00222
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 20, 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 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 DURING A RADIO FREQUENCY ABLATION PROCEDURE, WATER LEAKED FROM THE GRIP. ANOTHER NEEDLE ELECTRODE WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SINGLE, 20 CMX 3 C ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK