BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOLOGY BRUSH

    MDR report key: 3052828 · Received April 5, 2013

    Report

    Report Number
    MW5029697
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE CYTOLOGY BRUSH WAS ADVANCED THROUGH THE ERCP SCOPE THE BRUSH BENT IN THE SCOPE. WHEN PLACED IN THE BILE DUCT THE DISTAL TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139650 CYTOLOGY BRUSH CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC 4500 15330002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR