BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7500435 · Received May 9, 2018

    Report

    Report Number
    2647580-2018-02402
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 28, 2018
    Report Date
    June 7, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (MODEL #, CATALOG #, EXPIRATION DATE, 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 BILIARY AND INTESTINAL ANASTOMOSIS, WHILE CUTTING THE JEJUNUM, THE STAPLER AND ITS LOADING UNIT DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THEY USED OTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343877 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030449

    Patients

    Seq Age Sex Outcome Treatment
    1