BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR

    MDR report key: 1950687 · Received January 6, 2011

    Report

    Report Number
    3005075853-2011-00064
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    September 7, 2010
    Report Date
    November 9, 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. INSTRUMENT B: (B)(4), EXP DATE: 10/13/2014; MFR DATE: 11/13/2009; (B)(4). THE ANALYSIS RESULTS FOUND THAT THE 6TB45 DEVICE A, WAS RECEIVED WITH THE FIRING TRIGGER BROKEN AND WITH A 6R45B RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT SPRING NORMAL. 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 AND THE LEFT PINION AXLE SUPPORT WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON THICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). THE ANALYSIS RESULTS FOUND THAT THE 6TB45 DEVICE B WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS AND THE FIRING TRIGGER WAS NOTED TO BE IN GOOD VISUAL CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FIRST STAPLER WAS USED FOR TWO FIRINGS BUT ON THE THIRD FIRING THE FIRING-HANDLE BROKE, THEN A NEW ENDOCUTTER ON THE FIRST FIRING THE STAPLER LOCKED. THE SURGEON COULD NOT FIRE IT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4R06G

    Patients

    Seq Age Sex Outcome Treatment
    1