BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE MODEL EI-740D/S

    MDR report key: 18932180 · Received March 19, 2024

    Report

    Report Number
    1000513161-2024-00019
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 19, 2024
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP# (B)(4).

    Description of Event or Problem · 0

    ON FEBRUARY 12TH, 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EI-740D/S. IT WAS REPORTED THAT THE UP/DOWN ANGULATION CONTROL KNOB IS NOT WORKING DUE TO BROKEN METAL CABLE. SINCE THE CABLE BROKE, THE USER WAS NOT ABLE TO ANGULATE IT PROPERLY TO REMOVE IT FROM PATIENT. THERE WAS ABOUT 10 TO 15 MIN DELAY BECAUSE THE USER HAD TO FIND A WAY ON HOW TO ANGULATE THE SCOPE IN ORDER TO REMOVE IT FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324744 ENDOSCOPE MODEL EI-740D/S GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS FUJIFILM CORPORATION EI-740D/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown