BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWA PERCUTANEOUS ANTENNA 12CM

    MDR report key: 1214053 · Received October 23, 2008

    Report

    Report Number
    1717344-2008-00451
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL ANTENNAS WERE DISPOSED OF BY THE SITE. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT FOLLOWING A MICROWAVE ABLATION PROCEDURE ON THE LEFT LOBE OF THE LIVER, A 2ND DEGREE BURN WAS DISCOVERED ON THE SKIN. THREE ANTENNAS WERE USED IN A TOTAL OF 3 SEPARATE ABLATIONS OF 10 MINUTES EACH AT 45W. IN THE INITIAL ABLATIONS, 3 ANTENNAS WERE PLACED 1.5 - 2.0 CM APART IN A TRIANGLE. THEY WERE INSERTED 10 CM DEEP AND WERE 2.5 CM APART AT THE TIPS BASED ON ULTRASOUND PLACEMENT. ON 2ND ABLATION, THEY MOVED THE POSITIONING OF ONE OF THE ANTENNAS TO COMPLETE A SQUARE CONFIGURATION. THE INJURY OCCURRED IN THE CENTER OF THE SQUARE. ON 3RD ABLATION, THE SURGEON WITHDREW 3 ANTENNAS AND RE-INSERTED ONE ANTENNA. THE INJURY WAS NOTED AFTER THE 3RD ABLATION. ALL ANTENNAS WERE DISPOSED OF BY THE SITE. TREATED GAUZE WAS APPLIED TO THE INJURY AND THE PATIENT LEFT THE NEXT DAY AFTER THE SURGEON EXAMINED THE BURN AND REPORTED IT AS A NON-SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK