BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL CHANNELSCOPE

    MDR report key: 23438847 · Received October 31, 2025

    Report

    Report Number
    MW5178388
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 28, 2025
    Report Date
    October 28, 2025
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GWG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CLARUS MEDICAL LLC IS ISSUING THIS URGENT FIELD SAFETY NOTICE REGARDING AN ERROR IN THE DIRECT PRODUCT IDENTIFICATION MARKED ON THE PROXIMAL CONNECTOR OF THE DEVICE FOR THE AFFECTED LOTS LISTED ABOVE. THE ERROR: THE LASER ETCHING ON THE PROXIMAL CONNECTOR OF THE DEVICE INCORRECTLY DISPLAYS THE PRODUCT CATALOG/PART NUMBER FOR: MODEL 2230-521 (INCORRECT) INSTEAD OF MODEL 2233-521(CORRECT). CRUCIALLY: THE OUTER AND INNER PACKAGE LABELS (BOX AND PEEL POUCH) ARE CORRECT AND ACCURATELY IDENTIFY THE CONTENTS AS THE INTENDED PRODUCT. THE POTENTIAL ERROR ONLY EXISTS ON THE DIRECT PRODUCT MARKING ITSELF. LOT 521404. TOTAL UNITS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076668 DIGITAL CHANNELSCOPE ENDOSCOPE, NEUROLOGICAL GWG CLARUS MEDICAL, LLC. 2233-521 521404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown