BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORTECH AUTOLITH EHL PROBE

    MDR report key: 389179 · Received April 18, 2002

    Report

    Report Number
    1450997-2002-00001
    Event Type
    Other
    Date Received
    April 18, 2002
    Date of Event
    January 1, 2002
    Report Date
    April 17, 2002
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ELECTROHYDRAULIC LITHOTRIPTER PROBE 1.9FR USED FOR PROCEDURE. AT END OF PROCEDURE, IT WAS NOTED THAT THE TIP OF THE PROBE WAS NOT INTACT. THE TIP WAS VISUALIZED VIA FLUOROSCOPY IN THE PT'S URETER AT THE END OF THE CASE. PHYSICIAN WAS NOT ABLE TO RETRIEVE THE PIECE DUE TO POOR VISUALIZATION FROM POST-OPERATIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTECH AUTOLITH EHL PROBE ELECTROHYDRAULIC LITHOTRIPSY PROBE. FFK NORTHGATE TECHNOLOGIES INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization MAY RETURN TO OPERATING ROOM.