BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 7466590 · Received April 26, 2018

    Report

    Report Number
    2647580-2018-02131
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 8, 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

    CORRECTION:(MODEL #, CATALOG #, 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 PROCEDURE, WHILE INSTALLING THE DEVICE, IT COULD NOT BE CLAMPED. THEY TRIED TO UNLOAD THE "NAIL" AGAIN AND THEN INSTALLING BUT IT STILL COULD NOT BE CLAMPED. THEY REPLACED THE DEVICE SO THE OPERATION CAN CONTINUE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE INSTALLING THE DEVICE, IT COULD NOT BE CLAMPED. THEY TRIED TO UNLOAD THE "NAIL" AGAIN AND THEN INSTALLING BUT IT STILL COULD NOT BE CLAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308189 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1