BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 15-INCH MONITOR

    MDR report key: 12122746 · Received July 6, 2021

    Report

    Report Number
    9615393-2021-00205
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 14, 2021
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLIDESCOPE CORE 15-INCH MONITOR AND A GLIDESCOPE CORE QUICKCONNECT CABLE USED IN THE PROCEDURE WERE RETURNED TO VERATHON FOR EVALUATION. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED CORE 15-INCH MONITOR AND CORE QUICKCONNECT CABLE AND WAS UNABLE TO CONFIRM THE DARK IMAGE ISSUE. THE CAMERA IMAGE QUALITY TEST WAS PERFORMED AND PASSED. 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 CORE 15-INCH MONITOR AND A GLIDESCOPE CORE QUICKCONNECT CABLE WERE RETURNED TO VERATHON FOR EVALUATION. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED CORE 15-INCH MONITOR AND COULD NOT CONFIRM AN IMAGE FAILURE. THE CUSTOMER'S CORE QUICKCONNECT CABLE WAS CONNECTED TO A KNOWN, GOOD, TEST BFLEX 5.8 BRONCHOSCOPE, THEN TO THE CUSTOMER'S CORE 15-INCH MONITOR. THE IMAGE WAS NORMAL. A KNOWN, GOOD, TEST CORE QUICKCONNECT CABLE WAS CONNECTED TO A KNOWN, GOOD, TEST BFLEX 5.0 BRONCHOSCOPE, THEN CONNECTED TO THE CUSTOMER'S CORE 15-INCH MONITOR. WHILE THE CUSTOMER'S CORE 15-INCH MONITOR POWERED ON, BOTH BFLEX DEVICES WERE DISCONNECTED AND RECONNECTED MULTIPLE TIMES WITHOUT FAILURE. THE QUICKCONNECT CABLES WERE SWAPPED BETWEEN PORTS A AND B. THE CONNECTION OF THE QUICKCONNECT CABLES WERE REVERSED AND ALL THE TESTS WERE REPEATED. THE IMAGE REMAINED NORMAL. THE CAMERA IMAGE QUALITY TEST WAS PERFORMED AND PASSED. THE CUSTOMER'S GLIDESCOPE CORE 15-INCH MONITOR AND A GLIDESCOPE CORE QUICKCONNECT CABLE WERE FORWARDED TO VERATHON CANADA FOR FURTHER INVESTIGATION. 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. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE CORE 15-INCH MONITOR, THE IMAGE WENT DARK AND TURNED A REDDISH/BLACK. THE CUSTOMER ALSO NOTED THAT THE IMAGE SOMETIMES WENT COMPLETELY BLACK. 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
    1020589 GLIDESCOPE CORE 15-INCH MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0404 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1