BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-450T5

    MDR report key: 17476563 · Received August 7, 2023

    Report

    Report Number
    3001722928-2023-00046
    Event Type
    Death
    Date Received
    August 7, 2023
    Date of Event
    March 1, 2008
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    PMA / PMN Number
    K183683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE PROVIDE THE FOLLOWING INFORMATION: USE OF DEVICES SUCH AS ENDOSCOPIC/ENTEROSCOPY OVERTUBES MAY BE ASSOCIATED WITH POTENTIAL COMPLICATIONS INCLUDING BUT NOT LIMITED TO MUCOSAL TRAUMA, ASPIRATION PNEUMONIA, PANCREATITIS AND/OR HYPERAMYLASEMIA. USERS ARE ENCOURAGED TO CLOSELY MONITOR PATIENTS FOR SUCH COMPLICATIONS DURING AND AFTER PROCEDURES AND TO APPROPRIATELY TREAT PATIENTS AS REQUIRED. HEPATIC ISCHEMIA HAS BEEN REPORTED AS AN ADVERSE EVENT ASSOCIATED WITH A PATIENT IN A PRONE POSITION UNDER GENERAL ANESTHESIA. USE OF THIS PRODUCT FOR A PATIENT UNDER SIMILAR CONDITIONS COULD ALSO RESULT IN HEPATIC ISCHEMIA. WHEN USING THIS PRODUCT FOR A PATIENT UNDER GENERAL ANESTHESIA, BE AWARE OF HIS/HER ANATOMIC ORIENTATION. USERS ARE ENCOURAGED TO CLOSELY MONITOR PATIENTS FOR HEPATIC ISCHEMIA DURING AND AFTER PROCEDURES AND TO APPROPRIATELY TREAT PATIENTS, AS REQUIRED. FUJIFILM WAS UNABLE TO INVESTIGATE THE SCOPE AND, THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN OCTOBER 1, 2021 AND OCTOBER 12, 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON SEPTEMBER 22, 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Description of Event or Problem · 0

    ON JUNE 18, 2023, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLING EN-450T. 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
    284319 FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-450T5 ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EN-450T N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death