BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA REVOLUTION BIPOLAR CLAMP

    MDR report key: 2111013 · Received April 20, 2011

    Report

    Report Number
    2953686-2011-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC., DBA ESTECH
    Product Code
    GEI
    PMA / PMN Number
    K100224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. EQUIVALENT SAMPLES WERE TESTED FROM THE SAME LOT AND FROM ANOTHER LOT. THE DEVICES WERE EVALUATED FOR FUNCTIONALITY. THE DEVICES MET ALL SPECIFICATIONS AND FUNCTIONED PROPERLY. THERE WERE NO ISSUES NOTED FOR THE FUNCTIONALITY OF THE DEVICES. ALSO, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    PATIENT 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 PATIENT. REFERENCE USER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBRA REVOLUTION BIPOLAR CLAMP COBRA REVOLUTION BIPOLAR CLAMP GEI ENDOSCOPIC TECHNOLOGIES, INC., DBA ESTECH 600-008I 012455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention