BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3010865 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01286
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION; IN ADDITION A FULLY FIRED CARTRIDGE RELOAD WAS RECEIVED. THE DEVICE WAS TESTED FOR FUNCTIONALITY 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 SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING AN OPEN TOTAL PANCREATECTOMY, SOME STAPLES ON THE BOTH SIDES UNFORMED AT THE 1ST FIRING WHEN THE DEVICE WAS USED ON THE DUODENUM. SOME UNFORMED STAPLES ON THE CUT LINE WERE PROTRUDED OBVIOUSLY. THE STAPLE HEIGHT WAS BLUE. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE AND OTHER CARTRIDGES (STAPLE HEIGHT WAS GOLD) WERE USED ON THE JEJUNUM TWICE TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    THE STAPLES WERE MALFORMED THROUGHOUT ALL THE STAPLE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114793 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C34X

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD# SR75