BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 7503654 · Received May 10, 2018

    Report

    Report Number
    2647580-2018-02425
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    February 21, 2018
    Report Date
    May 17, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (PT. IDENTIFIER), (BRAND NAME), (MODEL #, MODEL #, UDI),(PMA / 510(K) #) .IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN THE DEVICE WAS BEING USED IN INTESTINAL STRAP STAPLING, THE LOAD DID NOT FIRE AFTER PRESSING THE GREEN BUTTON. THE STAPLER WAS NOT ABLE TO FIRE, AND THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. TO RESOLVE THE ISSUE, THEY USED ANOTHER RELOAD AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345946 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1