BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 652431 · Received November 21, 2005

    Report

    Report Number
    652431
    Event Type
    Death
    Date Received
    November 21, 2005
    Date of Event
    November 7, 2005
    Report Date
    November 15, 2005
    Manufacturer
    OLYMPUS AMERICA INC ENDOSCOPY GROUP
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE TO BREAK UP AND REMOVE KIDNEY STONES, AN ULTRASONIC LITHOTRIPTOR SUCTION HOSE WAS INCORRECTLY INSERTED INTO THE ROLLER PUMP. INSTEAD OF SUCTIONING DEBRIS FROM THE FRACTURED STONES, AIR WAS PUMPED INTO THE PATIENT'S KIDNEY. FOLLOWING DISCOVERY OF THE MISCONNECTION, THE HOSE WAS REVERSED IN AN ATTEMPT TO RECOVER FROM THE MISTAKE, BUT THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED SHORTLY THEREAFTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death