BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR

    MDR report key: 1921166 · Received December 13, 2010

    Report

    Report Number
    3005075853-2010-07030
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 22, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE 6TB45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. 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. 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 A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON FIRED THE DEVICE BUT IT WAS STUCK AND NO FORMATION OF THE STAPLES WAS NOTICED, IT WAS HARD TO OPEN THE INSTRUMENT. THE STAFF REPLACED THE DEVICE WITH A NEW ONE AND CONTINUED WITH THE SURGERY. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TJ5F

    Patients

    Seq Age Sex Outcome Treatment
    1