BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORTECH AUTOLITH EHL PROBE

    MDR report key: 383373 · Received March 14, 2002

    Report

    Report Number
    MW1024436
    Event Type
    Injury
    Date Received
    March 14, 2002
    Date of Event
    March 11, 2002
    Report Date
    March 14, 2002
    Manufacturer
    NORTHGATE TECHNOLOGIES INC
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization RETRIEVAL OF DEVICE.| POSSIBILITY OF RETURN TO OPERATING ROOM FOR