BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWA PERCUTANEOUS ANTENNA 17CM

    MDR report key: 1160702 · Received August 29, 2008

    Report

    Report Number
    1717344-2008-00410
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU STATES: WARNINGS: INSUFFICIENT SPACING BETWEEN ANTENNAS MAY CAUSE EXTENSIVE CHARRING, DIFFICULTY IN REMOVING THE ANTENNA AND INJURY TO THE PT. WHEN USING MULTIPLE MWA ANTENNAS, USE IMAGE GUIDANCE TO ENSURE THAT THE SPACING BETWEEN ANY TWO ANTENNAS IS AT LEAST 1.5 CM.

    Description of Event or Problem · 1

    THE REPORT STATED THAT FOLLOWING A PERCUTANEOUS MICROWAVE ABLATION, A SKIN BURN WAS FOUND AT THE PENETRATION SITE OF THE MIDDLE ANTENNA OF THREE ANTENNAS USED IN A LINE. THE BURN WAS DESCRIBED AS WHITE WITH A RED RING AROUND THE PENETRATION SITE. THIS WAS A SINGLE ABLATION AT 45W FOR 10 MINS. THE SPACING BETWEEN ANTENNAS WAS ABOUT 1CM TO .5CM IN A LINE. THE TREATMENT WAS A 4X4 MEDICATED ADHESIVE PAD PUT OVER THE PUNCTURE SITES INSTEAD OF THE USUAL BAND-AID. THE ANTENNAS WERE DISCARDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MWA PERCUTANEOUS ANTENNA 17CM MICROWAVE ABLATION ACCESSORY NEY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK