BEUDAMED
    FDA Adverse Event Death Summary report: N

    EGIA 4 HANDLE STANDARD

    MDR report key: 8564878 · Received April 29, 2019

    Report

    Report Number
    MW5086251
    Event Type
    Death
    Date Received
    April 29, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 25, 2019
    Manufacturer
    COVIDIEN LLC
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A MALE WITH BLADDER AND PROSTATE CANCER WHO UNDERWENT A LEFT NEPHRECTOMY ON (B)(6) 2019, DUE TO POORLY FUNCTION HYDRONEPHROTIC LEFT KIDNEY WITH IN ABILITY TO TOLERATE NEPHROSTOMY TUBES. DURING SURGERY, A VASCULAR STAPLER WAS PLACED ACROSS THE RENAL VEIN AND ARTERY EN BLOC AND WAS FIRED. APPROX A FEW SECONDS AFTER, THERE WAS SIGNIFICANT BLOOD IN THE RETROPERITONEUM. RESCUE ATTEMPTS WERE UNSUCCESSFUL, AND THE PT EXPIRED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352972 EGIA 4 HANDLE STANDARD STAPLER, SURGICAL GAG COVIDIEN LLC EGIA 1418524

    Patients

    Seq Age Sex Outcome Treatment
    1 Death