BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR CUTTERS - NTLC

    MDR report key: 3802195 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03142
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 3, 2014
    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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE NTLC75 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS 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 AND NO CARTRIDGE WAS RETURNED FOR ANALYSIS. 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 RIGHT HEMICOLECTOMY PROCEDURE, WHEN FIRING THE GUN, THE LEVER WAS JAMMING ON THE FIRST FIRING. MORE THAN USUAL FORCE WAS REQUIRED TO FIRE THE GUN. THE GUN WAS RELOADED AND THE SAME PROBLEM OCCURRED. SURGEON DID A HAND ANASTOMOSIS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280843 LINEAR CUTTERS - NTLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E08UC

    Patients

    Seq Age Sex Outcome Treatment
    1