BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH BIPOLAR ELECTROHYDRAULIC LITHOTRIPTOR PROBE

    MDR report key: 6954242 · Received October 17, 2017

    Report

    Report Number
    MW5072770
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 13, 2017
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN ERCP WITH STONE RETRIEVAL, SHL AND STENT PLACEMENT PROCEDURE, THE EHL FIBER TIP BROKE OFF WITHIN THE BILE DUCT. THE TIP WAS NOT ABLE TO BE RETRIEVED AND THE LIP FELT THERE WAS MINIMAL RISK TO THE PATIENT DUE TO THE RETENTION OF THE ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734166 AUTOLITH BIPOLAR ELECTROHYDRAULIC LITHOTRIPTOR PROBE EHL PROBE LITHOTRIPTOR FFK NORTHGATE TECHNOLOGIES, INC. 1.9 FRENCH 250 CM AT212422

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR