BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12446018 · Received September 9, 2021

    Report

    Report Number
    1000513161-2021-00016
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    February 8, 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 (B)(6) 2021 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) WAS INFORMED OF AN INCIDENT THAT OCCURRED DURING AN ERCP PROCEDURE. CANNULATION OF THE COMMON BILE DUCT (CBD) WAS DIFFICULT AND TOOK OVER 30 MINUTES TO SUCCESSFULLY CANNULATE. AFTER SUCCESSFUL CANNULATION OF THE CBD WITH A GUIDEWIRE, A SPHINCTEROTOMY WAS PERFORMED AND A METALLIC STENT WAS DEPLOYED. AFTER EXAMINING THE STENT PLACEMENT, A CAUTERY EFFECT OR MINOR MUCOSAL BURN WAS SEEN UNDERNEATH THE PAPILLA AND NOT WHERE THE SPHINCTEROTOMY WAS PERFORMED. NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE BURN. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2021. THE MANUFACTURER REPORTED THIS EVENT TO FDA UNDER REPORT # 3001722928-2021-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344741 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other