BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 1932724 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07249
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A FULLY FIRED CARTRIDGE RELOAD LOADED ON THE DEVICE. IT WAS NOTED THAT THERE WAS TWO FORMED STAPLES PRESENT ON THE CARTRIDGE DECK. THE DEVICE WAS TESTED WITH A TEST CARTRIDGE AND FIRED FOR FUNCTIONALITY. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, WHEN THE SURGEON FIRED THE DEVICE ON THE INITIAL FIRING, HE FIRED ACROSS THE COLON BY THE SIGMOID CONNECTION TO THE RECTUM HE OBSERVED THE STAPLE LINE AND THE ROW OF STAPLES NEXT TO THE KNIFE BLADE AT THE DISTAL END WAS INCOMPLETE. THE SECOND AND THIRD ROW OF STAPLES HAD COMPLETELY FIRED. THE SURGEON DECIDED TO USE A DIFFERENT STAPLER DISTAL TO THE ORIGINAL STAPLE LINE THUS CUTTING THE ORIGINAL STAPLE LINES OUT AND PLACING A NEW STAPLE LINE. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T43T

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD = (B)(4)