BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GST GOLD RELOAD, 60MM, 6 ROW

    MDR report key: 8664001 · Received June 3, 2019

    Report

    Report Number
    3005075853-2019-19346
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014690
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH: R5971F. ADDITIONAL INFORMATION REQUESTED BUT NOT RECEIVED: IS THE CURRENT PATIENT STATUS KNOWN? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) INVESTIGATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE GST60D CARTRIDGE RELOAD WAS RETURNED UNFIRED WITH 13 DOUBLE DRIVERS AND 10 SINGLE DRIVERS MISSING MAKING THE RELOAD NON-FUNCTIONAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: IS THE CURRENT PATIENT STATUS KNOWN? YES , GOOD HEALTH. WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? NO (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE CARTRIDGE OPENED, BEFORE INSTALLING IT ON THE STAPLER, THE NURSE NOTICED THAT THE WHITE PUSHERS IS OUT OF THEIR POCKETS. PATIENT CONSEQUENCES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458468 GST GOLD RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. R40N9G 10705036014690

    Patients

    Seq Age Sex Outcome Treatment
    1