BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3011489 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01308
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 1, 2013
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - UNBLEMISHED; VIDEO THE ANALYSIS RESULTS FOUND THAT THE 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. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. A VIDEO OF THE SURGICAL PROCEDURE WAS RECEIVED AND CORROBORATED THE DEVICE ANALYSIS FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLORECTAL ANASTOMOSIS, THIS STAPLER FAILED TO RESECT THE BOWEL OR PROPERLY CLOSE THE STAPLES. IN ADDITION, THE STAPLE LINE WAS INCOMPLETE. THEREFORE, IN ORDER TO CARRY OUT AND FINISH THE CASE, THE SURGEON HAD TO REMOVE THE PARTIALLY CLOSED STAPLES AND RESECT THE RECTAL STUMP. THEN ANOTHER COLORECTAL ANASTOMOSIS WAS CREATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113491 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CP73

    Patients

    Seq Age Sex Outcome Treatment
    1