BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWA PERCUTANEOUS ANTENNA 17CM

    MDR report key: 1942333 · Received December 22, 2010

    Report

    Report Number
    1717344-2010-01005
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 LUNG ABLATION PROCEDURE, THE ANTENNA BROKE DURING THE POSITIONING OF THE ANTENNA IN THE BODY OF THE PATIENT. THE ANTENNA WAS REMOVED IN ONE PIECE. THE ABLATION WAS FINISHED WITH ANOTHER ANTENNA. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MWA PERCUTANEOUS ANTENNA 17CM MICROWAVE ABLATION ACCESSORY NEY COVIDIEN LP (VALLEYLAB) 185951

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR