BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 15-INCH MONITOR

    MDR report key: 11497303 · Received March 16, 2021

    Report

    Report Number
    9615393-2021-00066
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 12, 2021
    Report Date
    February 19, 2021
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    K183256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS RETURNED TO VERATHON FOR EVALUATION ALONG WITH A GLIDESCOPE CORE 15" MONITOR, A GLIDESCOPE CORE SMART CABLE, AND A GLIDESCOPE CORE QUICKCONNECT CABLE. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED DEVICES AND WAS UNABLE TO CONFIRM THE REPORTED IMAGE ISSUE. 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 GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS RETURNED TO VERATHON FOR EVALUATION ALONG WITH A GLIDESCOPE CORE 15" MONITOR, A GLIDESCOPE CORE SMART CABLE, AND A GLIDESCOPE CORE QUICKCONNECT CABLE. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED DEVICES AND WAS UNABLE TO CONFIRM THE REPORTED IMAGE ISSUE. THE VIDEO IMAGE WAS NORMAL WHEN THE CORE SMART CABLE WAS CONNECTED TO A SINGLE-USE BLADE OR A VIDEO BATON 2.0 LARGE. WHEN THE BFLEX 5.0 AND CORE QUICKCONNECT CABLE WERE CONNECTED TO THE MONITOR, A NORMAL IMAGE WAS PRODUCED. THE VERATHON TECHNICAL SERVICE REPRESENTATIVE RAN SEVERAL OTHER TESTS IN AN ATTEMPT TO REPRODUCE THE IMAGE ISSUE INCLUDING TESTING BOTH THE MONITOR'S "A" AND "B" PORTS WITHOUT NOTICEABLE DIFFERENCE IN VIDEO QUALITY. SEVERAL POWER CYCLES TESTS WERE RUN WITH THE CABLES CONNECTED AND NOT CONNECTED BUT THE IMAGE ISSUE WAS UNABLE TO BE REPRODUCED. ON COMPLETION OF EVALUATION, THE DEVICE WAS SENT TO VERATHON MEDICAL CANADA FOR FURTHER ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE WOULD GO BLACK AND RED MAKING THE ANATOMY UNRECOGNIZABLE. 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
    392467 GLIDESCOPE CORE 15-INCH MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0404 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1