BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12467464 · Received September 14, 2021

    Report

    Report Number
    1000513161-2021-00008
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 14, 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. DOCTOR WAS PERFORMING AN ERCP PROCEDURE FOR BILIARY STONE REMOVAL. CANNULATION OF THE COMMON BILE DUCT (CBD) AND SPHINCTEROTOMY WERE PERFORMED WITHOUT ISSUE. AFTER COMPLETING THE SPHINCTEROTOMY WITH A BOSTON SCIENTIFIC TRUE TOME 44 SPHINCTERTOME, A CAUTERY EFFECT OR MINOR MUCOSAL BURN WAS NOTICED ON MUCOSAL TO THE LEFT OF THE MAJOR PAPILLA. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER DIFFICULTIES. THERE IS NO DEATH ASSOCIATED WITH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368833 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other