BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 4232953 · Received November 6, 2014

    Report

    Report Number
    3005075853-2014-07694
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE NTLC75 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AS THE FIRING KNOB WAS DETACHED AND MISSING AND THE SLIP BLOCK ASSEMBLY WAS NOTED TO BE DAMAGED. THE DEVICE WAS RECEIVED WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. THE DAMAGE TO THE FIRING KNOB AND SLIP BLOCK ASSEMBLY IS CONSISTENT WITH HIGH (OUTSIDE INDICATED USE) STAPLE FORMING FORCES; HOWEVER THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE HIGHER LOADS. 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. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CONVENTIONAL OPEN BARIATRIC PROCEDURE, DURING GASTRIC STAPLING, THE THIRD BLUE RELOAD, THERE WAS LOCKING THAT FORCED THE CURSOR; IT'S BREAKDOWN OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714619 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DR1R

    Patients

    Seq Age Sex Outcome Treatment
    1 BRKBANTLC KIT