BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 17186945 · Received June 22, 2023

    Report

    Report Number
    1000513161-2023-00036
    Event Type
    Death
    Date Received
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT EI-580BT ENDOSCOPES WERE CULTURED AND TESTED POSITIVE. THE DATE THAT THE EVENT OCCURRED IS UNKNOWN. THE ENDOSCOPE WAS QUARANTINED AFTER INITIAL SAMPLING, AND NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. HOWEVER, DUE TO THE RESULT OF FUJIFILM CORPORATION'S FINAL INVESTIGATION OF THE INCIDENT, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060899 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION N/A N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death