BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE

    MDR report key: 1618815 · Received February 11, 2010

    Report

    Report Number
    1618815
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 11, 2010
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE USE OF A LOANER OLYMPUS NEPHROSCOPE AND AN OLYMPUS ULTRASONIC LITHOTRIPTOR WITH PROBE, METAL FLAKES WERE NOTED WITHIN THE PATIENT'S LEFT KIDNEY. THERE WAS AN IMMEDIATE HALT OF THE PROCEDURE. THERE WAS AN ATTEMPT TO SUCTION THE METAL FLAKES BY THE PHYSICIAN; BUT NOT ALL WERE ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE METHODS. ALL THE EQUIPMENT WAS EVALUATED AFTER THE CASE WAS COMPLETED. THE MACHINE WAS TAKEN TO BIO-MED WITH THE HAND PIECE. A PICTURE WAS TAKEN AND GIVEN TO THE OR MANAGER. THE DAMAGED PROBE WAS GIVEN TO THE OR MANAGER. THE LOANER SCOPE WAS RETURNED TO THE MANUFACTURER'S REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE LITHOTRIPTOR PROBE FFK OLYMPUS AMERICA INC. MAJ-985 #9XR

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO OTHER THERAPIES