BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3102240 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02183
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LARYNGECTOMY PROCEDURE, ON THE FIRST FIRING, THE SURGEON PLACED THE DEVICE ON THE LARYNX. THE STAPLER WAS CLOSED AND THE FIRING WAS DONE, THE SURGEON CUT THE REST OF THE TISSUE. THE SURGEON OPENED THE JAWS OF THE DEVICE AND DISCOVERED THERE WERE NO STAPLES IN CARTRIDGE. THE SURGEON REPLACED THE INSTRUMENT, AND CONTINUES THE OPERATION WITH OTHER MEANS. THE SURGEON REPORTED THAT HE DID NOT FILLED NOTHING UNUSUAL IN THE DEVICE BEFORE AND DURING THE FIRING, THERE WASN'T UNUSUAL SOUND AND THERE WASN'T NEED TO OPERATE UNUSUAL POWERED ON THE DEVICE. THERE WAS NO DAMAGE TO TISSUE OR TO THE PATIENT. THE SURGEON OVER-SEW THE OPEN TRANSECTION. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203265 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C799

    Patients

    Seq Age Sex Outcome Treatment
    1