BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE

    MDR report key: 3735270 · Received April 3, 2014

    Report

    Report Number
    3735270
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 3, 2014
    Manufacturer
    HOLOGIC, INC.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    CAVITY EVALUATION DEVICE RUPTURED AFTER INTRAOPERATIVE PLACEMENT BY SURGEON. DURING THE SURGICAL PROCEDURE, THE SURGEON TESTED THE INTEGRITY OF THE BALLOON COMPONENT OF THE CAVITY EVALUATION DEVICE BY INSTILLING 60 CC FLUID WITH NO ISSUES. THE FLUID WAS REMOVED, THE DEVICE WAS PLACED AND 45 CC FLUID WAS INSTILLED. THE SURGEON PROCEEDED TO EVALUATE PLACEMENT VIA ULTRASOUND EXAM, AND WAS UNABLE TO VISUALIZE THE BALLOON. THE SURGEON ATTEMPTED TO WITHDRAW FLUID FROM THE BALLOON AND AT THAT TIME FOUND THAT THE BALLOON HAD RUPTURED. THE DEVICE WAS REMOVED. A SECOND DEVICE WAS RE-EVALUATED THE SAME WAY, PLACED, AND UPON ULTRASOUND EXAM, FOUND TO BE INTACT AND IN THE PROPER POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203033 MAMMOSITE INSTRUMENT, MANUAL, SURGICAL JAQ HOLOGIC, INC. * 13F17RC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR