BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF ELECTRODE

    MDR report key: 1911607 · Received October 19, 2010

    Report

    Report Number
    1911607
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    April 21, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER RADIO FREQUENCY ABLATION AND BIOPSY OF A LIVER MASS, NOTED A 1.5CM DIAMETER DUSKY SKIN LESION AT SITE OF THE RFA RADIO FREQUENCY ABLATION NEEDLE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF ELECTRODE CLUSTER ELECTRODE GEI COVIDIEN VALLEYLAB * 180773
    2 BIOPINCE INSTRUMENT, BIOPSY KNW ANGIOTECH PHARMACEUTICALS INC * 92671X1B

    Patients

    Seq Age Sex Outcome Treatment
    1 *