BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2233-513 DIGITAL CHANNEL SCOPE

    MDR report key: 23903608 · Received December 28, 2025

    Report

    Report Number
    2183911-2025-00001
    Event Type
    Malfunction
    Date Received
    December 28, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 28, 2025
    Manufacturer
    CLARUS MEDICAL, LLC
    Product Code
    GWG
    UDI-DI
    00810004820012
    PMA / PMN Number
    K223615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) DIGITAL CHANNELSCOPE LACKED SUFFICIENT ADHESIVE WHICH CAUSED IRRIGATION LEAK INTO (B)(6) CONTROL MODULE. THIS CAUSED THE PICTURE TO GO BLACK. INVESTIGATION AND CORRECTIVE ACTION IS ONGOING.

    Description of Event or Problem · 0

    DURING A CASE ON 10/24 USING A MODEL (B)(6) DIGITAL CHANNELSCOPE LOT # 520261, THE MONITOR WENT BLACK. THEY UNPLUGGED THE DEVICE AND NOTICED IRRIGATION FLUID COMING OUT OF THE CONNECTOR. THEY ATTEMPTED A NEW MODEL (B)(6) DIGITAL CHANNELSCOPE AND IT DID NOT DISPLAY AN IMAGE. THEY DID NOT HAVE A BACKUP (B)(6) DIGITAL CONTROL MODULE ON HAND, SO THEY SWITCHED TO A DIFFERENT SYSTEM TO FINISH THE CASE. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790115 2233-513 DIGITAL CHANNEL SCOPE CHANNEL SCOPE GWG CLARUS MEDICAL, LLC 2233-513 520261 00810004820012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other