BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 15-INCH MONITOR

    MDR report key: 11844476 · Received May 18, 2021

    Report

    Report Number
    9615393-2021-00137
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 22, 2021
    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 GLIDESCOPE CORE 15-INCH MONITOR WAS RETURNED TO VERATHON FOR EVALUATION. A VERATHON ENGINEER EVALUATED THE RETURNED DEVICE AND WAS ABLE TO REPRODUCE THE REPORTED "DARK IMAGE" ISSUE. DUE TO THE EXTENSIVE TESTING DONE TO THIS DEVICE TO INVESTIGATE THE FOLLOWING ISSUE, VERATHON HAS PROACTIVELY DECIDED TO REPLACE THE CUSTOMER'S GLIDESCOPE CORE 15-INCH MONITOR WITH ANOTHER. UPON COMPLETION OF VERATHON'S INVESTIGATION A REPLACEMENT GLIDESCOPE CORE 15-INCH MONITOR WAS SENT TO THE CUSTOMER. VERATHON HAS COMPLETED ITS INVESTIGATION OF THE REPORTED DARK IMAGE ISSUE FOR THE COMBINATION OF THE GLIDESCOPE 15-INCH MONITOR IN CONJUNCTION WITH A GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE IN CAPA-2021-0003. MEASUREMENTS OF THE ANALOG VIDEO SIGNAL WERE TAKEN WHEN A DARK IMAGE WAS DISPLAYED. THE ANALOG VIDEO CLOCK SIGNAL TIMING WAS OBSERVED TO BE DELAYED, RESULTING IN THE TRANSMISSION OF THE DARK IMAGE. A DESIGN REVIEW WAS CONDUCTED, THE DELAY WAS DETERMINED TO BE RESULT OF TWO RESISTOR SETS IN THE BFLEX RECEPTACLE. IMPROVING ONE OR BOTH RESISTOR SETS WAS SHOWN TO REDUCE OR ELIMINATE THE INSTANCES OF DARK IMAGE. VERIFICATION SAMPLES WERE PRODUCED WITH THE COMPONENT IMPROVEMENTS MADE ON THE BFLEX RECEPTACLE, DESIGN VERIFICATION WAS COMPLETED, AND AN ENGINEERING CHANGE ORDER (ECO) WAS RELEASED TO IMPLEMENT THE CHANGES. AS PART OF THE INVESTIGATION A POST LAUNCH RISK ASSESSMENT (PLRA) WAS PERFORMED. THE PLRA DETERMINED THAT THE OBSERVED SEVERITY AND PROBABILITY OF OCCURRENCE FOR THIS FAILURE MODE WERE IN ALIGNMENT WITH THE PREDICTED SEVERITY AND PROBABILITY OF OCCURRENCE. DURING THE PLRA, COMPLAINT DATA WAS REVIEWED. IN ALL INSTANCES THE USER COMPLETED AN UNPLUG/PLUG SEQUENCE TO RESTORE FUNCTIONALITY OR SWITCHED TO A BACKUP DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED. BASED ON THIS REVIEW OF THE SYSTEM RISK ASSESSMENT AND THE COMPLAINT DATA NO ADDITIONAL ACTION IS REQUIRED, VERATHON WILL CONTINUE TO MONITOR FOR TRENDS. ALL FORWARD PRODUCTION INCORPORATES THIS CHANGE.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE CORE 15-INCH MONITOR, THE IMAGE WAS SHADOWY AND DARK. 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
    742382 GLIDESCOPE CORE 15-INCH MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0404 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown