BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWA PERCUTANEOUS ANTENNA 22CM

    MDR report key: 1912917 · Received November 18, 2010

    Report

    Report Number
    1717344-2010-00893
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 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 RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN REC'D FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADD'L INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED. COVIDIEN IS FOLLOWING UP WITH THEIR REP AND THE DOCTOR TO REVIEW THE PROCEDURE AND TECHNIQUE FOR THIS UNUSUAL NUMBER OF BROKEN ANTENNAS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MICROWAVE ABLATION PROCEDURE THE ANTENNA BROKE. THERE WAS NO COMPLICATION OR INJURY TO THE PT AND IT WAS EASILY REMOVED INTACT THROUGH THE SKIN WITH ONLY A DELAY OF SEVERAL MINS. THE ABLATION CASE WAS FINISHED SUCCESSFULLY. IT WAS REPORTED THAT MULTIPLE ANTENNAS BROKE IN 2 PROCEDURES WITH THIS DOCTOR. THIS PROCEDURE INCLUDED MFR REPORT #1717344-2010-00889, 1717344-2010-00890, 1717344-2010-00891, 1717344-2010-00894.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MWA PERCUTANEOUS ANTENNA 22CM MICROWAVE ABLATION ACCESSORY NEY COVIDIEN LP (VALLEYLAB) 183912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK