BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE RELOAD FOR ECHELON

    MDR report key: 3243002 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03687
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 2013
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE, DAMAGED ONE PIECE SLED THE ANALYSIS RESULTS SHOWED THAT ONE ECR60W WAS RETURNED WITH THE CARTRIDGE DECK, AND THE ONE PIECE SLED DAMAGED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED GETS DAMAGED. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE ONE PIECE SLED CAN BREAK THROUGH THE CARTRIDGE RELOAD WALL ALLOWING THE FIRING TO CONTINUE. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. DUE TO THE CONDITION OF THE RELOAD, NO FUNCTIONAL TEST COULD BE PERFORMED. IT SHOULD BE NOTED THAT EACH CARTRIDGE RELOAD IS 100% INSPECTED THROUGH AN AUTOMATED VISION SYSTEM TO ENSURE THAT THE ONE PIECE SLED AND ALL STAPLES ARE PRESENT PRIOR TO SHIPMENT. 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 AN UNKNOWN PROCEDURE THIS WAS THE SECOND RELOAD AND THE DEVICE COULD NOT FIRE WITH IT. THE STAFF CHANGED TO ANOTHER ONE TO COMPETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344256 WHITE RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1