BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2233-513 DIGITAL CHANNEL SCOPE

    MDR report key: 23953012 · Received January 3, 2026

    Report

    Report Number
    2183911-2025-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    December 3, 2025
    Report Date
    January 3, 2026
    Manufacturer
    CLARUS MEDICAL, LLC
    Product Code
    GWG
    UDI-DI
    00810004820012
    PMA / PMN Number
    K223615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    2233-513 DIGITAL CHANNELSCOPE LACKED SUFFICIENT ADHESIVE WHICH CAUSED IRRIGATION LEAK INTO 5190-500 CONTROL MODULE.

    Description of Event or Problem · 0

    DURING THE CASE 12/3/25 THEY HAD AN ISSUE WITH A MODEL 2233-513 DIGITAL CHANNELSCOPE (LOT 520504) LEAKING IRRIGATION FLUID OUT OF THE IMAGE CONNECTOR AND INTO THE DIGITAL CONTROL MODULE. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14358 2233-513 DIGITAL CHANNEL SCOPE CHANNEL SCOPE GWG CLARUS MEDICAL, LLC 2233-513 520504 00810004820012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown