BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3133330 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02600
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. DAMAGED RELEASE BUTTON THE ANALYSIS FOUND THAT DEVICE (A) WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM WAS NOTED TO BE WORN OUT; IT APPEARS THAT THE DEVICE WAS FORCED OPEN WITH THE KNIFE NOT IN THE HOME POSITION. THE DAMAGE OF THE CLAMP ARM CAUSES THE DEVICE NOT HOLDING IN THE CLOSED POSITION. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS FOUND THAT DEVICE (B) WAS RECEIVED FOR ANALYSIS AND WITH ONE ECR60W CARTRIDGE UNFIRED LOADED IN THE DEVICE . FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM WAS NOTED TO BE WORN OUT, IT APPEARS THAT THE DEVICE WAS FORCED OPEN WITH THE KNIFE NOT ON THE HOME POSITION. THE DAMAGE OF THE CLAMP ARM CAUSES THE DEVICE NOT HOLDING IN THE CLOSED POSITION. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH THE RETURNED CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL PROCEDURE, THEY WERE STAPLING THE MOMENTUM WITH A WHITE RELOAD THE FIRST TWO FIRINGS WERE FINE, THE THIRD FIRING WHEN THEY CLOSED THE LOCKING HANDLE AFTER 15 SECONDS IS POPPED OPEN AND WOULD NOT STAY CLOSED. THEY OPENED ANOTHER LIKE DEVICE AND THE FIRST RELOAD FIRED CORRECTLY AND THE SECOND FIRING THE DEVICE WOULD NOT STAY CLOSED. THERE WAS NO FIRING ON TISSUE AT EITHER TIME DUE TO THE DEVICE WOULD NOT STAY CLOSED TO FIRE THE DEVICES. THEY USED ANOTHER DEVICE AND IT WORKED FINE. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236918 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C94V

    Patients

    Seq Age Sex Outcome Treatment
    1