BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 659840 · Received November 28, 2005

    Report

    Report Number
    659840
    Event Type
    Death
    Date Received
    November 28, 2005
    Date of Event
    November 7, 2005
    Report Date
    November 28, 2005
    Manufacturer
    OLYMPUS AMERICA INC. ENDOSCOPY GROUP
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE TO BREAK UP AND REMOVE KIDNEY STONES, A SUCTION HOSE WAS INCORRECTLY INSERTED INTO THE ROLLER PUMP OF THE OLYMPUS LITHOTRIPTOR LUS2. INSTEAD OF SUCTIONING DEBRIS FROM THE KIDNEY (I.E., FRACTURED STONES) AIR WAS INADVERTENTLY PUMPED INTO THE KIDNEY. FOLLOWING DISCOVERY OF THE MISCONNECTION, THE HOSE WAS REVERSED IN AN UNSUCCESSFUL ATTEMPT TO RECOVER FROM THE MISTAKE. THE PATIENT WENT INTO CARDIAC ARREST, AND WAS PRONOUNCED DEAD ON THE OR TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LITHOTRIPTER, ULTRASONIC, INVASIVE FEO OLYMPUS AMERICA INC. ENDOSCOPY GROUP LUS-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death