BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3935514 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04960
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE FIRING CYCLE, UNCUT WASHER - UNBLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED IN GOOD VISUAL CONDITION VOID OF STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. IT SHOULD BE NOTED THAT BEFORE FIRING, ENSURE THAT THE ORANGE INDICATOR IS FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE AND THE ANVIL IS REATTACHED CORRECTLY. TO REATTACH THE DETACHABLE HEAD OR ANVIL DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. NOT REATTACHING THE ANVIL CORRECTLY OR THE ORANGE INDICATOR NOT BEING SET ON THE GREEN RANGE WILL RESULT IN A BIGGER GAP BETWEEN THE ANVIL AND THE GUIDE FACE, THEREFORE THE STAPLES WILL NOT HIT THE ANVIL TO MAKE B- FORMED STAPLES. IN ADDITION IF THE FIRING SEQUENCE IS NOT COMPLETE, STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN UNKNOWN PROCEDURE, AFTER FIRING THE DEVICE, THE OPERATOR OBSERVED LEAKAGE AT THE STAPLING SITE THAT HE HAD TO DO REINFORCE SUTURE TO MAKE SURE THE STAPLING WAS SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413612 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E29O

    Patients

    Seq Age Sex Outcome Treatment
    1