BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 60 ENDO LINEAR

    MDR report key: 1860263 · Received October 7, 2010

    Report

    Report Number
    3005075853-2010-05768
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE LTS60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION, SEVERAL B-FORMED STAPLES WERE RECEIVED INSIDE OF A BAG. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS, MIDDLE LOBE PROCEDURE THE FIRST FIRING WITH A GREEN LOAD WAS FINE. THE DEVICE WAS RELOADED WITH A GREEN LOAD AND THE DEVICE TORE SOME OF THE TISSUE. THE DEVICE CUT AND STAPLED. WHEN THE DEVICE WAS REMOVED THERE WERE SOME MALFORMED STAPLES ON THE DISTAL PORTION OF THE CARTRIDGE. THE REP STATED THAT THERE WAS NO BLEEDING. ANOTHER DEVICE WAS PULLED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 60 ENDO LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4PH2H

    Patients

    Seq Age Sex Outcome Treatment
    1 TR60G, E4LX82