BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 2M QUICKCONNECT CABLE

    MDR report key: 23124705 · Received September 23, 2025

    Report

    Report Number
    9615393-2025-00109
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 16, 2025
    Report Date
    September 23, 2025
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S GLIDESCOPE CORE 2M QUICKCONNECT CABLE WAS NOT RETURNED TO VERATHON FOR EVALUATION, THEREFORE THE CAUSE COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER "18193-1-21" DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS REPORTED TO VERATHON. TRENDING ANALYSIS FOR THE GLIDESCOPE CORE QUICKCONNECT CABLES DOES NOT IDENTIFY ANY TRENDS EXCEEDING ACCEPTABLE LIMITS. VERATHON CONFIRMED THAT THE RISK ASSOCIATED WITH THE HAZARDOUS SCENARIO HAS BEEN ADEQUATELY CAPTURED AND CHARACTERIZED PER THE SYSTEM RISK ASSESSMENT. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, WHILE USING A GLIDESCOPE CORE 2 M QUICKCONNECT CABLE, THE SCREEN ON THE CONNECTED GLIDESCOPE CORE MONITOR FROZE AND GLITCHED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT GLIDESCOPE CORE QUICKCONNECT CABLE. AN UNSPECIFED DELAY IN CARE WAS REPORTED BUT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209716 GLIDESCOPE CORE 2M QUICKCONNECT CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0600-0843 18193-1-21

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown