BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2801492 · Received October 23, 2012

    Report

    Report Number
    3005075853-2012-04823
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 29, 2012
    Report Date
    October 2, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE 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. EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE, DURING THE INITIAL FIRING OF A DEVICE ACROSS THE STOMACH WITH A BLACK RELOAD STAPLE LEGS WERE OBSERVED MIDWAY UP THE STAPLE LINE WITH THE DEVICE CLOSED FULLY AND THE KNIFE BLADE AT THE DISTAL END OF THE END EFFECTOR. TEN OR SO STAPLES ON THE OUTERMOST ROW ON THE LEFT SIDE OF THE STAPLE LINE WERE MALFORMED. THE TWO INNER ROWS OF STAPLES WERE PERFECTLY FORMED. THE CASE WAS COMPLETED WITHOUT INCIDENT AND THE DEVICE WAS USED FOR SIX MORE FIRINGS. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C88V

    Patients

    Seq Age Sex Outcome Treatment
    1