BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM NTLC SELECTABLE RELOAD

    MDR report key: 3172572 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03051
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 23, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION. THE CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN JEJUNECTOMY, "THE DOCTOR COMMENTED THAT THE STAPLES DEPLOYED SPOTS AND IT DID NOT DRAW A LINE". THE STAPLE HEIGHT WAS BLUE. AS NO ANOMALIES IN STOPPING BLEEDING, ADDITIONAL SUTURE WAS NOT PERFORMED AND THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE TARGET TISSUE WAS NORMAL. THERE WERE NO PROBLEMS IN FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273862 75MM NTLC SELECTABLE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1