BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 18028893 · Received October 30, 2023

    Report

    Report Number
    18028893
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    June 2, 2023
    Report Date
    October 10, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    UDI-DI
    10884523003543
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A ROBOTIC ASSISTED LAPAROSCOPIC RIGHT RADICAL NEPHRECTOMY. THERE WAS A STAPLER MALFUNCTION, WHERE IT WOULD NOT COMPLETELY CLOSE AND THE HANDLE OF THE LAPAROSCOPIC STAPLER WAS QUICKLY EXCHANGED, WHILE THE SURGEON HELD INCOMPLETE CONTROL OF BLEEDING THAT APPEARED TO COME FROM THE RENAL VEIN. THE RENAL VEIN AND ARTERY WERE STAPLED IN BLOC WITH MULTIPLE STAPLE LOADS AND HEMOSTASIS WAS RESTORED. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156217 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW COVIDIEN LP EGIAUSTND P3B0201 10884523003543

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Male