BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 3193083 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03317
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION 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 B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A SURGICAL PHOTOGRAPH WAS RECEIVED AND IT IS BELIEVED THE COMPLICATION WAS THE RESULT OF LINEAR DECK DEFLECTION AND TISSUE FLOW RESULTING FROM THE COMBINATION OF BUTTRESSING MATERIAL AND TISSUE THICKNESS WAS BEYOND THE DEVICE¿S (LONG60A) ABILITY TO BRING THE TISSUE INTO THICKNESS COMPLIANCE UTILIZING A GREEN STAPLE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THIS WAS THE FIRST FIRING OFF THE PYLORUS ON A LAP SLEEVE GASTRECTOMY¿.SO THIS WAS THE FIRST STAPLE FIRING- WE DID NOT CROSS ANOTHER STAPLE LINE WHEN THE EVENT HAPPENED. THE CROWNS IN THE MIDDLE OF THE STAPLE LINE WERE WAVY. THE VERY PROXIMAL AND THE DISTAL PORTIONS OF THE STAPLE LINE WERE PERFECT AND TO THE END OF THE CUT LINE AS THEY SHOULD BE. THE MIDDLE PORTION HAD OPEN LEGGED STAPLES¿.COMPLETELY UNFORMED. APPROXIMATELY 20 MINUTES WAS ADDED TO THE CASE FOR NECESSARY OVERSEWING OF THE STAPLE LINE. POST OPERATIVE CARE OF THE PT. DID NOT CHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE FIRST FIRING WITH A GREEN CARTRIDGE AND SEAM GUARD THE STAPLE LINE WAS UNEVEN AND CROWNS WERE WAVY. THE LEGS WERE NOT FORMED ON THE UNDERSIDE. THEY WERE NOT FORMED AT ALL. THE SURGEON THEN OVER SEWED THE STAPLE LINE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE DEVICE WILL BE RETURNED BY THE OPERATING ROOM MATERIALS COORDINATOR. THE STAPLE CARTRIDGE WAS DISPOSED OF. THERE WERE NO PATIENT CONSEQUENCES OTHER THAN EXTENDING OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292802 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CP8G

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G