BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR CUTTER

    MDR report key: 1945509 · Received January 4, 2011

    Report

    Report Number
    3005075853-2011-00032
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 8, 2010
    Report Date
    November 13, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT AN ETS45 WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH SEVEN RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CUT AND FORMED THE STAPLES AS INTENDED. HOWEVER, THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE IN PREVIOUS FIRINGS. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SURGEON, AFTER FINISHING ALL THE DIFFERENT STEPS IN THE PROCEDURE, AND BEFORE CLOSING, REEXAMINES THE STAPLE LINES AND FINDS BLEEDING IN THE STAPLE LINES. THE SURGEON USES CLIPS TO ACHIEVE HEMOSTASIS. THE SURGEON DOES NOT FIND THIS TO BE ACCEPTABLE HEMOSTASIS AND HAS TO USE CLIPS TO LIGATE THE STAPLE LINE BLEEDING. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1