BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SING, 20CMX2CM KIT

    MDR report key: 2033114 · Received February 28, 2011

    Report

    Report Number
    1717344-2011-00158
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    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

    (B)(4). EVALUATION OF THE RETURNED ELECTRODE FOUND THE INSULATION DAMAGED. THE ELECTRODE FAILED HIPOT TESTING. THE INSULATION COULD HAVE BEEN DAMAGED DURING INSERTION INTO THE GUIDING NEEDLE. CARE MUST BE TAKEN WHEN INSERTING THE ELECTRODE INTO A GUIDING NEEDLE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING THE ABLATION PROCEDURE, THE DOCTOR NOTICED THAT THE GUIDING NEEDLE BECAME HEATED. THE ABLATION WAS STOPPED AND A MINOR BURN WAS NOTED AT THE NEEDLE INSERTION SITE. THE GUIDING NEEDLE BEING USED WAS METALLIC AND DOCTOR IS AWARE THAT THE GUIDING NEEDLE IS THE CAUSE OF THIS BURN. THE ACTUAL DEGREE OF BURN WAS NOT AVAILABLE BUT WAS REPORTED TO BE MINOR AND TREATED WITH OINTMENT. INITIAL EVALUATION OF THE INCIDENT ELECTRODE FOUND THE INSULATION WAS DAMAGED AND THE ELECTRODE FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SING, 20CMX2CM KIT RF ABLATION ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 169960

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK