BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE RELOAD

    MDR report key: 2133522 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02480
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT. THE ANALYSIS RESULTS SHOW THAT ONE (B)(4) RELOAD WAS RECEIVED PARTIALLY FIRED 01/16 AND WITH THE PAN PARTIALLY DETACHED. IN ADDITION, THE STAPLE RETAINER WAS RECEIVED BROKEN. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, AT THE TIME OF FIRING THE CARTRIDGE IT DOES NOT PROGRESS AND REMAINED LOCKED INSURANCE STAPLER. ANOTHER LIKE CARTRIDGE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4393J

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR