BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES ARM

    MDR report key: 3823840 · Received February 21, 2014

    Report

    Report Number
    2953686-2014-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ESTECH
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    TUESDAY, (B)(6) 2014 WHILE PERFORMING A PROCEDURE WITH DR (B)(6), HE ASKED FOR THE ESTECH HERCULES HEART HOLDER 2 FINGER SHORT TO HELP SUPPORT THE HEART IN A HELPFUL ORIENTATION. WHEN HE BEGAN TO TIGHTEN THE INSTRUMENT TO MAKE IT RIGID, THE TIGHTENING CABLE BROKE WHICH CAUSED ALL THE INDIVIDUAL PIECES OF THE HERCULES TO FALL INTO THE OPEN CHEST. A X-RAY WAS TAKEN AT THE CONCLUSION OF THE CASE TO RULE OUT ANY RETAINED PIECES. X-RAY FILM WAS CLEARED BY ATTENDING RADIOLOGIST (B)(6). SURGICAL ATTENDING NOTIFIED OF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109384 HERCULES ARM HERCULES ARM DWS ESTECH 401-152 71022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention