BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM 600 SERIES ENDOSCOPE EC-600WM

    MDR report key: 21204907 · Received January 22, 2025

    Report

    Report Number
    3001722928-2024-00036
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    November 6, 2024
    Report Date
    January 22, 2025
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE EC-600WM IS SIMILAR TO EC-600WL(510(K) NUMBER;K132210) MARKETED IN U.S., FUJIFILM SUBMIT THIS MDR. THE UDI-DI FOR EC-600WL IN THE UNITED STATES IS (B)(4). THIS EVENT WAS DETECTED BY A LOCAL AGENT ON THE NMPA WEBSITE IN CHINA. AND THE LOCAL AGENT VISITED THE FACILITY TO OBTAIN MORE DETAILED INFORMATION. THE RESULT OF THE POST-REPAIR CULTURE TEST WAS 0 CFU, SO IT IS THOUGHT THAT THE CAUSE WAS DUE TO AIR LEAK OF THE FORCEPS CHANNEL.

    Description of Event or Problem · 0

    THIS ENDOSCOPE WAS TAKEN OUT OF SERVICE AFTER 5150 CFU FROM THE FORCEPS CHANNEL WERE DETECTED IN A CULTURE TEST CONDUCTED BY THE FACILITY. THE FACILITY CONDUCTED ANOTHER CULTURE TEST AFTER CLEANING AND DISINFECTING THE ENDOSCOPE AGAIN, BUT 50 CFU WERE DETECTED. AFTER THIS, AN AIR LEAK WAS DETECTED FROM THE FORCEPS CHANNEL, AND THE FACILITY ASKED A THIRD PARTY TO REPLACE AND REPAIR THE FORCEPS CHANNEL. THE RESULT OF THE CULTURE TEST AFTER THE REPAIR WAS 0 CFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713793 FUJIFILM 600 SERIES ENDOSCOPE EC-600WM COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF FUJIFILM CORPORATION EC-600WM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown