BEUDAMED
    FDA Adverse Event Other Summary report: N

    USI-2000A ULTRASONIC LITHOTRIPSY

    MDR report key: 767754 · Received October 3, 2006

    Report

    Report Number
    767754
    Event Type
    Other
    Date Received
    October 3, 2006
    Report Date
    September 28, 2006
    Manufacturer
    ACMI
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOANER INSTRUMENT SET UP FOR PERCUTANEOUS NEPHROLITHOTOMY. HANDPIECE ATTACHED TO MACHINE, FAULT LIGHT CAME ON AND FLASHED. COULD NOT BE SUCCESSFULLY ATTACHED AND WITHIN 5TH ATTEMPT, ELECTRIC SHOCK TO EMPLOYEE. TESTED OK, BUT FAULT LIGHT DID NOT TURN OFF. NO HARM TO PT (NEPHROLITHOTOMY DONE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USI-2000A ULTRASONIC LITHOTRIPSY SYSTEM USC-DH FEO ACMI UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other