BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH

    MDR report key: 8470353 · Received March 29, 2019

    Report

    Report Number
    MW5085400
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 27, 2019
    Manufacturer
    US ENDOSCOPY GROUP, INC.
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RADIOPAQUE MARKER DISLODGED IN COMMON BILE DUCT. ADDITIONAL PROCEDURE NEEDED TO REMOVE AND TREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256097 US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH CYTOLOGY BRUSH FDX US ENDOSCOPY GROUP, INC. 00711653 1809100

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization