BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GST GOLD RELOAD, 60MM, 6 ROW

    MDR report key: 9425780 · Received December 6, 2019

    Report

    Report Number
    3005075853-2019-24024
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    July 15, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014690
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNK. MAUDE REPORT NUMBER: MW# 5090668. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS BATCH/LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE SURGEON WAS USING AN ETHICON STAPLE GUN DURING A PROCEDURE. THEY DID NOT HAVE ANY COMPLICATIONS UNTIL THE SECOND TO LAST STAPLE WAS BEING FIRED. DURING THIS COMPLICATION, THE STAPLER FIRED BUT ONLY ONE SIDE OF THE GOLD LOAD STAPLES FIRED CORRECTLY. THE SPECIMEN PORTION OF THE STOMACH WAS NOTED TO HAVE A HOLE IN IT. THE PATIENT DID NOT SUSTAIN ANY INJURIES AND THIS WAS CONFIRMED INTRAOPERATIVELY WITH AN EGD AND LEAK TEST THAT WAS PERFORMED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228979 GST GOLD RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. T40L2E 10705036014690

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR