BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON LIGACLIP APPLIER

    MDR report key: 14843551 · Received June 27, 2022

    Report

    Report Number
    MW5110542
    Event Type
    Death
    Date Received
    June 27, 2022
    Date of Event
    March 9, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRITICALLY ILL PATIENT UNDERWENT A NEPHRECTOMY AND HAD TO RETURN TO SURGERY FOR BLEEDING WHERE IT WAS DISCOVERED THE HEMORRHAGE WAS FROM THE RIGHT ADRENAL GLAND WITH A CLIP FAILURE. ADDITIONAL CLIPS REMAINED PARTIALLY OCCLUDING THE RENAL VEIN, BUT NOT ENOUGH TO STOP BLOOD FLOW. THERE WAS A SMALL DEFECT APPROXIMATELY 1 MM IN THE VENA CAVA DIRECTLY POSTERIOR TO THE VEIN, WHERE THE SURGEON SUSPECTS THE TIP OF THE CLIP HAD PINCHED THE VENA CAVA WHEN IT WAS PLACED OR WHEN IT FAILED, IT MADE A SMALL HOLE. PATIENT UNDERWENT A MASSIVE TRANSFUSION BUT ULTIMATELY WAS UNABLE TO RECOVER FROM HIS SURGERY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018315 ETHICON LIGACLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO SURGERY, INC. MCL20 175A96

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death