BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-450T5

    MDR report key: 17511667 · Received August 11, 2023

    Report

    Report Number
    1000513161-2023-00052
    Event Type
    Death
    Date Received
    August 11, 2023
    Date of Event
    March 1, 2008
    Report Date
    August 11, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLING (B)(4). UPON REVIEWING LITERATURE, IT WAS FOUND THAT 48 COMPLICATIONS OCCURRED USING THE SCOPE. ACUTE PANCREATITIS OCCURRED IN 9 PATIENTS WITH 1 LETHAL COURSE OF DISEASE. PERFORATION OCCURRED IN 8 CASES, ALL OF THEM NEEDED SURGERY. ONE PATIENT DIED DURING THE COURSE OF THE DISEASE. 6 PERFORATIONS OCCURRED AFTER POLYPECTOMY. LN 6 CASES, MAJOR BLEEDING WAS REPORTED, 4 IN THE CONTEXT OF POLYPECTOMY AND 2 AFTER BIOPSY. ALL PATIENTS RECEIVED ENDOSCOPIC TREATMENT AND RECOVERED FROM THIS COMPLICATION. THE EXACT DATE OF THE EVENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596441 FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-450T5 ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EC-600WL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death