BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3961736 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05265
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 11, 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
    TX, US
    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 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. 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 RIGHT COLECTOMY PROCEDURE, THE DEVICE WAS FIRED FOR FIFTH TIME AND AS THE FIRING KNOB WAS RETURNED TO IT'S ORIGINAL POSITION, THE FIRING KNOB BROKE OFF AT THE CURVE OF HANDLE. THE FIRING KNOB DID NOT FALL INTO PATIENT. THE CASE WAS COMPLETED AT THAT POINT, SO NO NEW DEVICE WAS NEEDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439353 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1