BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3896936 · Received June 26, 2014

    Report

    Report Number
    3005075853-2014-04436
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = INCOMPLETE FIRING CYCLE, UNCUT WASHER - BLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) 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 WITH A TEST WASHER; 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FIRED BUT STAPLES DID NOT FORM PROPERLY (POOR STAPLE FORMATION) AND THE ANASTOMOSIS WAS NOT COMPLETE, BUT THERE WAS NO BLEEDING. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374119 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E91C

    Patients

    Seq Age Sex Outcome Treatment
    1