BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA REVOLUTION

    MDR report key: 2052145 · Received March 25, 2011

    Report

    Report Number
    2052145
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES INC, DBA ESTECH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING REPAIR OF ASCENDING AORTA AND MAZE PROCEDURE. THE BALL AT THE TIP OF THE ESTECH MAZE DEVICE BROKE OFF AND WAS FOUND IN THE OPEN CHEST CAVITY. THE BALL WAS RETRIEVED FROM THE CHEST WITH NO HARM/INJURY TO THE PT.======================MANUFACTURER RESPONSE FOR BIPOLAR CLAMP, COBRA REVOLUTION======================THE COMPANY SALES REP REPRESENTATIVE IS AWARE. WE HAD 2 ADDITIONAL DEVICES WITH SAME LOT NUMBER THAT WERE REMOVED AND REPLACED BY THE COMPANY REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBRA REVOLUTION BIPOLAR CLAMP GEI ENDOSCOPIC TECHNOLOGIES INC, DBA ESTECH * 012455

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR