BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS

    MDR report key: 1871305 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05885
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 15, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH; SPRING CARTRIDGE LOCKOUT TAB THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AS THE FIRING TRIGGER HANDLE WAS BROKEN. A RELOAD WAS LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. 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 AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED AFTER CLOSING. THEN THE SURGEON FIRED WITH THE HIGHER FORCE, THE FIRING TRIGGER WAS BROKEN. AT LAST, THE SURGEON USED HAND SEWING TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4IF4W

    Patients

    Seq Age Sex Outcome Treatment
    1