BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH**

    MDR report key: 2170426 · Received July 20, 2011

    Report

    Report Number
    3005075853-2011-02906
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B: BATCH # (B)(4), EXP DATE: 12/19/2015; 01/19/2011. THE ANALYSIS RESULTS FOUND THAT LONG60 DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE LONG60 INSTRUMENT B WAS RECEIVED WITH NO VISUAL NON-CONFORMANCES. THE DEVICE WAS LOADED WITH AN UNFIRED RELOAD. UPON FURTHER INSPECTION OF THE RELOAD, THE ONE-PIECE SLED WAS FOUND DAMAGED. IMPROPER LOADING OF THE RELOAD MAY DAMAGE THE SLED. IF THE RELOAD IS NOT FULLY SEATED WHEN THE DEVICE IS CLOSED, THE SLED WILL BREAK. WHEN INSERTING THE RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE RELOAD JAW UNTIL THE RELOAD ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE INSTRUMENT IS NOW LOADED AND READY FOR USE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. EVENT COULD NOT BE CONFIRMED AS THE RELOAD THAT ALLEGEDLY PRODUCE THE INCOMPLETE STAPLE LINE WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE STAPLE LINE WAS NOT COMPLETE ON ONE SIDE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE WITH CARTRIDGES FROM A DIFFERENT LOT NUMBER. NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON* 60 ENDOPATH** STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1