BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON

    MDR report key: 5972684 · Received September 21, 2016

    Report

    Report Number
    MW5064971
    Event Type
    Death
    Date Received
    September 21, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ETHICON US, LLC
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT EMPHYSEMATOUS PYELONEPHRITIS FOR WHICH A URETERAL STENT HAD BEEN PLACED. WITH CONTINUED EVIDENCE OF INFECTION, A LEFT NEPHRECTOMY WAS RECOMMENDED. THE SURGICAL APPROACH BEGAN LAPAROSCOPICALLY AND WAS UNEVENTFUL, WITH ISOLATION OF THE RENAL VESSELS. THE ETHICON STAPLER WAS POSITIONED OVER THE ARTERY AND DEPLOYED. THERE WAS NO EVIDENCE OF BLEEDING UNTIL THE JAWS OF THE STAPLER WERE OPENED AND MASSIVE BLEEDING WAS NOTED. THE PROCEDURE WAS IMMEDIATELY CONVERTED TO AN OPEN PROCEDURE WITH THE RENAL ARTERY CLAMPED AND BLEEDING CONTROLLED. HOWEVER, THE PT'S BP DROPPED AND SHE WENT INTO PEA ARREST. DESPITE AGGRESSIVE RESUSCITATION MEASURES, INCLUDING BLOOD PRODUCT REPLACEMENT, THE PT WAS NOT ABLE TO BE RESUSCITATED. UPON EXAMINATION BY THE SURGEON FOLLOWING THE DEATH, IT WAS NOTED THAT THE STAPLES IN THE STAPLE LINE DID NOT APPEAR TO LIE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619916 ECHELON FLEX POWERED VASCULAR STAPLER GDW ETHICON US, LLC PVE35A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death