BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 2M QUICKCONNECT CABLE

    MDR report key: 23065215 · Received September 16, 2025

    Report

    Report Number
    9615393-2025-00108
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 16, 2025
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    UDI-DI
    00879123006578
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DECLINED THE OPTION TO HAVE THEIR GLIDESCOPE CORE 2M QUICKCONNECT (QC) CABLE RETURNED TO VERATHON FOR EVALUATION, THEREFORE THE CAUSE COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED QC CABLE LOT NUMBER 18350-1-4 IDENTIFIED ONE (1) PREVIOUS COMPLAINT REPORTED TO VERATHON; HOWEVER, THE REPORTED ISSUE FOR THAT QC CABLE WAS UNRELATED TO IMAGE FREEZING. TRENDING ANALYSIS FOR GLIDESCOPE CORE 2M QC 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 THE SCREEN ON THEIR GLIDESCOPE CORE 10-INCH MONITOR WAS INTERMITTENTLY FREEZING DURING INTUBATION AND RESULTED IN A DELAY IN TREATMENT. FOLLOW-UP INFORMATION FROM THE CUSTOMER REPORTED ISOLATING THE ISSUE TO THE GLIDESCOPE CORE 2M QUICKCONNECT CABLE THAT WAS CONNECTED TO THE MONITOR. NO USE OF A BACKUP DEVICE OR HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680008 GLIDESCOPE CORE 2M QUICKCONNECT CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0600-0843 18350-1-4 00879123006578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown