BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOSWIFT CLEANING BRUSH AND 1 VALVE/CONTROL HEAD BRUSH

    MDR report key: 6002805 · Received October 4, 2016

    Report

    Report Number
    MW5065211
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 4, 2016
    Manufacturer
    US ENDOSCOPY
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A CLEANING BRUSH FOR AN ENDOSCOPE BROKE OFF DURING USE. PRODUCT IS SINGLE USE AND WAS FOUND IN ONE OF THE CHANNELS OF THE SCOPE. MANUFACTURER IS US ENDOSCOPY, WITH REF #(B)(4) , AND IS PACKAGED AS 1 DUOSWIFT CLEANING BRUSH AND ONE VALVE/CONTROL HEAD BRUSH. THE BRUSH TIP WAS FROM THE CLEANING BRUSH NOT THE HEAD BRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649760 DUOSWIFT CLEANING BRUSH AND 1 VALVE/CONTROL HEAD BRUSH DUOSWIFT CLEANING BRUSH AND 1 VALVE/CONTROL HEAD BRUSH MNL US ENDOSCOPY 00711619 1611558

    Patients

    Seq Age Sex Outcome Treatment
    1