BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM VIDEO ENDOSCOPE EC-600LS

    MDR report key: 18139948 · Received November 15, 2023

    Report

    Report Number
    1000513161-2023-00076
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Report Date
    November 15, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    UDI-DI
    04547410330229
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMMENT OF "BROKEN KNOB" IS CONFIRMED WITH BSA UP WIRE IS BROKEN, DWA DRUM WIRES FRAYED, ISA PEELING, ANG LOOSE/OFF.

    Description of Event or Problem · 0

    ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING WITH EC-600LS. IT WAS REPORTED THAT THE KNOB BROKE DURING THE PROCEDURE PRIOR TO REACHING CECUM AND THE KNOB WAS UNABLE TO ROTATE. THERE WAS A DELAY TO SWITCH TO A DIFFERENT SCOPE. THERE WAS NO INJURY TO THE PATIENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907078 FUJIFILM VIDEO ENDOSCOPE EC-600LS COLONOSCOPE AND ACCESSORIES FDF FUJIFILM CORPORATION EC-600LS N/A 04547410330229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other