BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 656288 · Received December 21, 2005

    Report

    Report Number
    8010047-2005-00130
    Event Type
    Death
    Date Received
    December 21, 2005
    Date of Event
    November 7, 2005
    Report Date
    December 15, 2005
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED DURING A PROCEDURE TO BREAK UP AND REMOVE KIDNEY STONES, AN ULTRASONIC LITHORIPTOR SUCTION HOSE WAS INCORRECTLY INSERTED INTO THE ROLLER PUMP. INSTEAD OF SUCTIONING DEBRIS FROM THE FRACTURED KIDNEY STONES, AIR WAS PUMPED INTO THE PT'S KIDNEY. FOLLOWING THE DISCOVERY OF THE MIS-CONNECTION, THE HOSP REPORTED THE HOSE WAS REVERSED IN AN ATTEMPT TO RECOVER FROM THE MISTAKE. HOWEVER, THE PT'S ELECTROCARDIOGRAM BEGAN TO SHOW SIGNS THE PT WAS UNDER STRESS AND THE PT WENT INTO CARDIAC ARREST. THE PT WAS UNABLE TO BE REVIVED AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC LITHOTRIPTOR FEO OLYMPUS OPTICAL CO. LTD. LUS-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death