BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 8824370 · Received July 24, 2019

    Report

    Report Number
    2647580-2019-03851
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003543
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 LAPAROSCOPIC FUNDUPLICATION PROCEDURE, WHEN THE DOCTOR TRIED TO FIRE THE STAPLER, THE STAPLER AND LOAD WAS STUCK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. DIFFICULTY IN UNLOADING THE STAPLER WAS ALSO REPORTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616179 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND P8G0147X 10884523003543

    Patients

    Seq Age Sex Outcome Treatment
    1