BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO CLIP II

    MDR report key: 1633881 · Received February 18, 2010

    Report

    Report Number
    1633881
    Event Type
    Death
    Date Received
    February 18, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 18, 2010
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A HAND-ASSISTED LAPAROSCOPIC RIGHT RADICAL NEPHRECTOMY FOR A RIGHT RENAL MASS. THERE WERE TWO (2) DEVICES USED DURING THIS PROCEDURE, THE CLIP APPLIER AND THE STAPLER WITH TWO DIFFERENT-SIZED RELOADS. THE CLIP APPLIER WAS USED TO ADDRESS THE OVARIAN ARTERY. WHEN THE PHYSICIAN TRIED TO DEPLOY THE CLIP, THE DEVICE CUT INSTEAD OF CLIPPING THE OVARIAN ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE CUT END OF THE ARTERY AND CLIP USING THE SAME DEVICE. THE RENAL ARTERY AND RENAL VEIN WERE ADDRESSED WITH THE STAPLING DEVICE AND RELOADS. VISUAL INSPECTION OF THE SURGICAL FIELD BEFORE ENDING THE PROCEDURE SHOWED NO EVIDENCE OF BLEEDING. THE PATIENT DEVELOPED A DROP IN HEMOGLOBIN IN THE RECOVERY ROOM AND A COMPUTERIZED AXIAL TOMOGRAPHY (CT) SCAN SHOWED A MODERATE-SIZED HEMATOMA ALONG THE HILUM OF THE KIDNEY AS WELL AS BLOOD LEAKAGE FROM THE RENAL ARTERY. THE ARTERIAL PHASE OF THE CT SCAN SHOWED THAT THERE WAS AN ARTERIAL LEAK. PATIENT WAS TAKEN TO THE INTERVENTIONAL RADIOLOGY SUITE WHERE THE RENAL ARTERY WAS EMBOLIZED USING COILS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND AGAIN DEVELOPED SIGNS OF INTRA-ABDOMINAL BLEEDING. THE PATIENT DIED IN THE INTENSIVE CARE UNIT FROM ACUTE BLOOD LOSS. AN AUTOPSY IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP II CLIP APPLIER GDO COVIDIEN UNITED STATES SURGICAL CORPORATION * *
    2 ENDO GIA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * *
    3 ENDO GIA ROTICULATOR RELOAD, STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * *
    4 ENDO GIA ROTICULATOR RELOAD, STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death