BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARUS DIGITAL CHANNELSCOPE ENDOSCOPE, 13.0CM

    MDR report key: 24129812 · Received January 21, 2026

    Report

    Report Number
    24129812
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 3, 2025
    Report Date
    January 5, 2026
    Manufacturer
    CLARUS MEDICAL, LLC
    Product Code
    GWG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY, DR. WAS USING THE CHANNEL SCOPE IN THE PATIENTS BRAIN FOR VISUALIZATION, WHEN THE SCREEN SUDDENLY WENT BLACK. THE SCOPE WAS IMMEDIATELY REMOVED FROM THE BRAIN, AND WHEN THE NURSE EXAMINED THE CLARUS BOX THE SCOPE WAS PLUGGED INTO, THEY DISCOVERED THERE WAS WATER INSIDE THE CONNECTION SITE. THE TEAM REALIZED WATER FROM THE SCOPE IRRIGATION WAS FLOWING DOWN THE CORD, INTO THE PLUG, CAUSING THE BOX TO SHORT OUT, AND THE SCREEN TO GO BLACK. THE CHANNEL SCOPE WAS REMOVED FROM THE FIELD, AND A DIFFERENT SCOPE SYSTEM WAS USED TO PROCEED WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191688 CLARUS DIGITAL CHANNELSCOPE ENDOSCOPE, 13.0CM ENDOSCOPE, NEUROLOGICAL GWG CLARUS MEDICAL, LLC 2233-513 520204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female