BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2861449 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05497
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 14, 2012
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN X-RAY PHOTOGRAPH OF THE STAPLES AND STAPLE LINE WAS RECEIVED. BASED ON THE REVIEW, THE STAPLES DO NOT APPEAR TO BE FROM THE REPORTED DEVICE AS THE STAPLES OBSERVED ON THE PHOTOGRAPH HAVE 2-DIMENSIONAL STAPLE FORM AND STAPLES FROM THIS REPORTED DEVICE HAVE A 3-DIMENSIONAL FORM. FOLLOW UP WAS CONDUCTED TO VERIFY PRODUCT CODE. INFORMATION RECEIVED BACK INDICATED THAT THIS WAS THE DEVICE USED IN THE SURGICAL PROCEDURE. THE STAPLE FORM APPEAR TO GET WORST FROM PROXIMAL TO DISTAL (TOP LEFT TO LOWER RIGHT) WHICH WOULD NOT BE CONSISTENT WITH STAPLES FROM THE REPORTED DEVICE BASED ON THE DESIGN. HENCE AGAIN PRESENTS THE QUESTION OF DEVICE USED IN THE FIRING AND STAPLE LINE CREATION. IT WAS CONCLUDED THAT THE COMPLICATION WAS THE RESULT OF A DEVICES ANVIL AND STAPLE CARTRIDGE JAWS BEING OUT OF ALIGNMENT DURING FIRING. THE EVENT DESCRIPTION SUPPORTS THE FORCES THAT WOULD BE EXPERIENCED DURING A MISALIGNMENT FIRING. HOWEVER THE X-RAY PHOTOGRAPH DOES NOT SUPPORT THAT THE COMPLICATION WAS AS A RESULT OF THE MISALIGNMENT OF THE REPORTED DEVICE.

    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. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. A TISSUE SAMPLE WAS RECEIVED AND ANALYZED. THE STAPLES DO NOT APPEAR TO BE FROM THE DEVICE INDICATED IN THE EVENT. ADDITIONAL FOLLOW UP IS BEING CONDUCTED TO VERIFY PRODUCT CODE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE WHEN FIRING THE STAPLER THERE WAS A LOT OF RESISTANCE, ESPECIALLY WHEN PULLING THE KNIFE BACK. FORCE WAS USED TO OPEN THE STAPLER. THE STAPLES WERE NOT FORMED PROPERLY AND THE ANASTOMOSIS WAS NOT SUFFICIENT. ANASTOMOSIS WAS HAND SEWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1