BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12446039 · Received September 9, 2021

    Report

    Report Number
    1000513161-2021-00017
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    March 16, 2021
    Report Date
    September 9, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    14547410359289
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON MARCH 17, 2021 FUJIFILM MEDICAL SYSTEMS U.S.A. WAS INFORMED OF AN INCIDENT THAT OCCURRED DURING AN ERCP PROCEDURE INVOLVING THE ED-580XT DUODENOSCOPE. DURING A SPHINCTEROTOMY, A MUCOSAL BURN WAS NOTICED PROXIMAL TO THE AMPULLA AND AWAY FROM THE CUTTING WIRE OF THE SPHINCTEROTOME. NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE BURN. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 03-17-2021. THE MANUFACTURER REPORTED THIS EVENT TO FDA UNDER REPORT # 3001722928-2021-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345267 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other