BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 4202007 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07359
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: FROM THE AFFILIATE: WHILE FIRING THE DEVICE, THE HOUSING HALVES JUST UNDER THE INDICATOR WINDOW SLIGHTLY OPENED, SO THE DOCTOR STOPPED FIRING. THE ANALYSIS RESULTS FOUND THAT THE CDH29 DEVICE ARRIVED IN GOOD VISUAL CONDITION WITH SEVERAL STAPLES PROTRUDING INSIDE THE POCKETS AND SOME ON THE DEVICE GUIDE FACE. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY, THE CUTTING SOUND OF WASHER WAS NOT HEARD. ALTHOUGH THE TARGET TISSUE WAS CUT, STAPLES WERE NOT DEPLOYED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS USED ON A COLORECTAL ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684720 PROXIMATE ILS CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ED8W

    Patients

    Seq Age Sex Outcome Treatment
    1