BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP SINGLE ELEC 15CM X 1 CM KIT

    MDR report key: 1870453 · Received October 6, 2010

    Report

    Report Number
    1717344-2010-00678
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ABLATION PROCEDURE, WITH THE ELECTRODE IN CORRECT PLACEMENT, THE GENERATOR WOULD NOT ACTIVATE DUE TO HIGH IMPEDANCE. THE ELECTRODE WAS REPOSITIONED AND ABLATION RESTARTED, BUT THE GENERATOR STILL REGISTERED HIGH IMPEDANCE. THE ORTHOPAEDIC SURGEON CURETTED THE OSTEOID AND REPOSITIONED THE ELECTRODE AGAIN, BUT IT STILL WOULDN'T WORK. THE DOCTOR THEN INJECTED A SMALL AMOUNT OF SALINE INTO OSTEOID AND RESTARTED THE GENERATOR. THE CYCLE STARTED. AFTER 1 MIN, THE CYCLE STOPPED DUE TO A SURFACE BURN ON THE PT'S SKIN AROUND THE ELECTRODE PLACEMENT. THE ABLATION PROCEDURE WAS STOPPED, THE ELECTRODE REMOVED, AND THE SMALL BURN WAS DRESSED WITH JELONET AND MELONIN DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELEC 15CM X 1 CM KIT RF ABLATION ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 177909

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR