BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWA PERCUTANEOUS ANTENNA 12CM

    MDR report key: 1900069 · Received November 9, 2010

    Report

    Report Number
    1717344-2010-00777
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED 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 A PERCUTANEOUS MICROWAVE ABLATION TREATMENT OF A 2 CM LIVER CANCER TUMOR, AN ANTENNA BROKE INSIDE THE PT. IT WAS BACKED OUT ALONG ITS INSERTION PATH AND WAS REMOVED INTACT IN A SINGLE PIECE. A SECOND ANTENNA WAS OBTAINED AND AGAIN INSERTED AND IT TOO BROKE INSIDE THE PT. LIKE THE FIRST ANTENNA, IT WAS BACKED OUT ALONG ITS INSERTION PATH AND WAS REMOVED INTACT IN A SINGLE PIECE. A THIRD ANTENNA WAS USED AND COMPETED THE PROCEDURE SUCCESSFULLY. ULTRASOUND WAS USED FOR GUIDANCE AND PLACEMENT OF THE ANTENNAS. THE REPLACEMENTS OF ANTENNAS ADDED 45 MINUTES TO THE PROCEDURE. THERE WAS NO PT INJURY. SEE MFR REPORT # 1717344-2010-00778 FOR OTHER ANTENNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MWA PERCUTANEOUS ANTENNA 12CM MICROWAVE ABLATION ACCESSORY NEY COVIDIEN LP, (VALLEYLAB) 169698

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR