BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORTHGATE

    MDR report key: 10322 · Received November 10, 1993

    Report

    Report Number
    2429304-1993-00157
    Event Type
    Other
    Date Received
    November 10, 1993
    Date of Event
    September 1, 1993
    Report Date
    September 27, 1993
    Manufacturer
    NORTHGATE
    Product Code
    FGM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ELECTROHYDROLIC LITHOTRIPSY, A 3 FR PROBE DISINTEGRATED IN THE PATIENT'S URETER. SOME OF THE METAL PIECES SCATTERED AND PERFORATED THE URETER. A STENT WAS PLACED IN THE URETER. THE RECOMMENDED SETTING ON THE ELECTROHYDRAULIC LITHOTRIPTER IS 65 AND THE HOSPITAL HAD THE UNIT SET AT 67.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTHGATE 3 FR PROBE FGM NORTHGATE 9360 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other