BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    MDR report key: 18585770 · Received January 26, 2024

    Report

    Report Number
    3001722928-2024-00007
    Event Type
    Death
    Date Received
    January 26, 2024
    Date of Event
    December 1, 2023
    Report Date
    January 26, 2024
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EN-450T5/W HAS NOT MARKETED IN THE UNITED STATES. THIS MDR IS SUBMITTED BECAUSE SIMILAR DEVICE EN-450T5(510(K):K183683) WAS MARKETED IN THE UNITED STATES. THERE WERE NO ABNORMALITIES LEADING TO ADVERSE EVENTS IN THE DEVICE USED. THE PHYSICIAN ALSO DID NOT COMPLAIN OF ANY ABNORMALITY IN THE DEVICE. IN PATIENTS HAVING UNDERGONE SURGICAL (GI) RECONSTRUCTION, GASTROINTESTINAL INSUFFLATION PRESSURES MAY EASILY INCREASE. THIS AIR COULD HAVE INVADED THE BLOOD VESSELS. FOR THIS REASON, THE FOLLOWING IS LISTED IN THE IFU. " IN PATIENTS HAVING UNDERGONE SURGICAL (GI) RECONSTRUCTION, GASTROINTESTINAL INSUFFLATION PRESSURES MAY EASILY INCREASE WITHOUT NOTICE AND AIR OR GAS MAY ENTER AN INJURED OR DAMAGED BLOOD VESSEL. PATIENT CONDITIONS SHOULD ALWAYS BE CAREFULLY MONITORED. IF AN EMBOLISM IS SUSPECTED, IMMEDIATELY STOP THE PROCEDURE AND TAKE APPROPRIATE ACTION. "

    Description of Event or Problem · 0

    THE PATIENT HAD CONGENITAL BILIARY ATRESIA AND HAD GASTROINTESTINAL RECONSTRUCTION BY KASAI SURGERY SHORTLY AFTER BIRTH. A DOUBLE-BALLOON ENDOSCOPY WAS PERFORMED TO DIAGNOSE OBSCURE GASTRO-INTESTINAL BLEEDING. DURING OBSERVATION OF THE GASTROINTESTINAL TRACT, THE PATIENT'S BLOOD PRESSURE DROPPED, HIS CONDITION SUDDENLY CHANGED, AND HE WENT INTO CARDIAC ARREST. THE PATIENT WAS RESUSCITATED BUT DIED. A CT SCAN REVEALED AN AIR EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135527 FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EN-450T5/W

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Death