BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20466097 · Received October 16, 2024

    Report

    Report Number
    2955842-2024-20557
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 20, 2024
    Report Date
    September 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) AND PERSONALITY MODULE SURGEON CONSOLE (PMSC) BOARD FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WERE ANALYZED, AND THE FOLLOWING INVESTIGATION RESULTS WERE OBTAINED: HIGH-RESOLUTION STEREO VIEWER (HRSV): THE MONITOR WAS INSTALLED AND TESTED IN THE PCA TEST SYSTEM. STARTED UP AND FAILED WITHOUT VIDEO ON THE DISPLAY. THE ONLY MESSAGE THAT WAS DISPLAYED WAS "NO SIGNAL". THE ISSUE WAS CONFIRMED. PERSONALITY MODULE SURGEON CONSOLE (PMSC): THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RUNNING VIDEO TEST, 1 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. SYSTEM CAME UP WITH NO ERRORS REPORTED AND AUDIO AND VIDEO WERE CLEAR. THE REPORTED ISSUE COULD NOT BE REPLICATED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND PERSONALITY MODULE SURGEON CONSOLE (PMSC) BOARD TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE HRSV OR THE PMSC BOARD FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE VISION ON THE SURGEON SIDE CONSOLE (SSC) RIGHT HIGH RESOLUTION STEREO VIEWER (HRSV) WAS OFF. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND COULD NOT FIND ANY ERRORS. THE TSE ASKED THE CALLER TO REMOVE THE ENDOSCOPE AND TRY THE COLOR BAR, BUT THE SSC RIGHT HRSV WAS ALWAYS OFF. THE SURGEON CONTINUED WITH ONE EYE IN THE SSC. THE TSE HAD THE CUSTOMER REBOOT THE SSC AND CLEAN THE BLUE FIBER CABLE, BUT THE PROBLEM WAS THE SAME. THE CUSTOMER WAS COMPLETING THE PROCEDURE ROBOTICALLY WITH MORE THAN 15 MINUTES DELAY. THERE WAS NO REPORTED INJURY. ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034593 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-09 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES