BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRIPTER EHL UNIT

    MDR report key: 11745 · Received February 25, 1994

    Report

    Report Number
    MW1000887
    Event Type
    Malfunction
    Date Received
    February 25, 1994
    Date of Event
    January 24, 1994
    Report Date
    February 14, 1994
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING DEVICE DURING LITHOTRIPSY PROCEDURE. PROBE TIP WAS DESTROYED AND BROKE OFF. IT WAS RETRIEVED. NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOTRIPTER EHL UNIT FFK NORTHGATE TECHNOLOGIES, INC. SD-100

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other