BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE ONETOUCH SMART CABLE

    MDR report key: 10240073 · Received July 7, 2020

    Report

    Report Number
    9615393-2020-00135
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    May 26, 2020
    Report Date
    May 28, 2020
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    85705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GLIDESCOPE CORE ONETOUCH SMART CABLE WAS RETURNED TO VERATHON FOR DESTRUCTION AND DISPOSAL. PREVIOUS INVESTIGATIONS AT VERATHON CANADA OF GLIDESCOPE CORE ONETOUCH SMART CABLES WERE ABLE TO DUPLICATE THE REPORTED INTERMITTENT IMAGE ISSUE. VERATHON'S INVESTIGATION DETERMINED THAT WHEN THE USER APPLIES A TWISTING MOTION WHILE ATTEMPTING TO CONNECT THE BLADE IN THE HDMI PORT OR APPLIES EXCESSIVE TORSION TO THE CONNECTION PORT (ADJACENT TO THE VIDEO CAPTURE / RECORD BUTTONS), THIS FORCE IS TRANSFERRED FROM THE HDMI CONNECTOR PORT TO THE HDMI PRINTED CIRCUIT BOARD (PCB), WHICH CONTROLS THE VIDEO SIGNAL. AS A RESULT, THERE IS AN INTERRUPTION IN THE VIDEO SYNCHRONIZATION SIGNAL. THIS CAUSES A TEMPORARY LOSS OF THE LIVE IMAGE. AS A RESULT, THE USER MAY EXPERIENCE AN INTERMITTENT IMAGE OR "BLANK SCREEN." IN SOME CASES, THE MONITOR WILL DISPLAY THE "NO CAMERAS CONNECTED" MONITOR WARNING. VERATHON INCORPORATED IS CONDUCTING A VOLUNTARY RECALL OF ALL GLIDESCOPE CORE ONETOUCH SMART CABLES DUE TO POTENTIAL INTERMITTENT OR COMPLETE LOSS OF IMAGE DURING USE. THE CUSTOMER WAS NOTIFIED OF THE RECALL AND PROVIDED A COMPATIBLE ALTERNATIVE REPLACEMENT CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE CORE ONETOUCH SMART CABLE, THE IMAGE WOULD FREEZE WHEN THE CABLE WAS MOVED. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702762 GLIDESCOPE CORE ONETOUCH SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0800-0601 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1