BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE ONETOUCH SMART CABLE

    MDR report key: 10146607 · Received June 11, 2020

    Report

    Report Number
    9615393-2020-00099
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 11, 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 · 0

    THE GLIDESCOPE CORE ONETOUCH SMART CABLE WAS RETURNED TO VERATHON FOR EVALUATION. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED GLIDESCOPE CORE ONETOUCH SMART CABLE AND CONFIRMED THAT THE CABLE SHOWED NO VIDEO WHEN THE BATON WAS CONNECTED. TECHNICAL SERVICES ATTRIBUTED THE ISSUE TO A CABLE FAILURE. THE GLIDESCOPE CORE ONETOUCH SMART CABLE WAS TARGETED 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN IS ANTICIPATED; HOWEVER, AT THE TIME OF THE REPORT THE DEVICE HAS NOT BEEN RECEIVED BY VERATHON. VERATHON CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. 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, THERE WAS NO CONNECTIVITY, NO PICTURE. A DELAY OF UNKNOWN DURATION OCCURRED AS A BACK-UP GLIDESCOPE CORE 10 WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610072 GLIDESCOPE CORE ONETOUCH SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0800-0601 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1