BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 21922521 · Received April 28, 2025

    Report

    Report Number
    2955842-2025-17320
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110782
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE RIGHT-SIDE MONITOR VOLTAGE HEAVILY LOADED ALL CONNECTED COMPONENTS, ULTIMATELY LOSING SEVERAL PARTS LIKE THE SURGEON BACK PLANE (SBP), PERSONALITY MODULE SURGEON CONSOLE (PMSC). DURING TROUBLESHOOTING, THE FSE SWAPPED GENERIC CART CONTROLLER (GCC) FROM SURGEON SIDE CONSOLE TO PATIENT SIDE CART. OUR GCC BOARD WENT BAD DURING THE SWAPPING, CORRUPTING THE LEFT MASTER TOOL MANIPULATOR (MTM) FILE. AFTER THE REPLACEMENT OF GCC LEFT MTM, THE CALIBRATION FILE WAS RESTORED, BUT LEFT MTM WAS NOT ABLE TO PERFORM HOMING AT THAT POINT. LEFT MTM WAS REPLACED TO RESOLVE THE ISSUE. ULTIMATELY, THE FSE FOUND THAT THE RIGHT MONITOR WAS THE CULPRIT FOR ALL THESE ISSUES; WE MUST REPLACE THE RIGHT MONITOR, BUT THE PART NUMBER AVAILABLE IN OUR STOCK WAS DIFFERENT. TO KEEP THE COMPATIBILITY, THE FSE HAD TO REPLACE BOTH MONITORS. THE SYSTEM WAS TESTED AND VERIFIED FOR USE. AS OF THE DATE OF THIS REPORT, THE SBP, PMSC, MTM, HRSV, AND GCC HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SURGEON BACK PLANE (SBP), PERSONALITY MODULE SURGEON CONSOLE (PMSC), MASTER TOOL MANIPULATOR (MTM), HIGH RESOLUTION STEREO VIEWER (HRSC), AND GENERIC CART CONTROLLER (GCC) TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO REPRODUCE NOR CONFIRM THE REPORTED COMPLAINT FOR THE SBP. DURING VISUAL INSPECTION, FA FOUND NO ISSUES RELATED TO THE REPORT ISSUE. THE SBP WAS INSTALLED AND TESTED INTO A GOLDEN PRINTED CIRCUIT ASSEMBLY SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE SYSTEM STARTED UP WITHOUT ANY ERROR. RAN 10X POWER CYCLE WITH THIS PART, ALL PASSED. EXERCISING ALL ARMS WITH NO ISSUE. THE SBP REMAINED ON THE TEST SYSTEM FOR HOURS. AS A RESULT OF THESE FINDINGS, FA CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE. FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE THE REPORTED COMPLAINT DURING IN-HOUSE TESTING FOR THE PMSC. DURING VISUAL INSPECTION, FA FOUND THE UNIT HAD CORROSION. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE PMSC. IT FAILED ERROR 45308. REPLICATING THE REPORTED EVENT. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT PMSC WAS FOUND TO BE THE ROOT CAUSE THE REPORTED EVENT. FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE DURING IN-HOUSE TESTING FOR THE HOMING ERROR ON THE MTM. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE SINE CYCLE WAS FOUND TO BE FAILING ON THE AXIS 5-7. ONCE TESTING WAS COMPLETED, THE AXIS 5-7 MOTORS WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT THE AXIS 5-7 MOTORS AND WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. FA WAS NOT ABLE TO CONFIRM NOR REPRODUCE THE REPORTED COMPLAINT FOR THE HRSV (#1). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITOR WAS INSTALLED ON OUR PCA TEST SYSTEM. IT STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. AS A RESULT OF THESE FINDINGS, FA WAS UNABLE TO DETERMINE TOOT CAUSE. FA WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING FOR THE HRSV (#2). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITOR WAS INSTALLED AND TESTED ON THE PCA TEST SYSTEM. POWERED ON SHOWING A BLANK SCREEN. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT AN ELECTRICAL COMPONENT ISSUE IN THE MONITOR WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED FAILURE. FA WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS NOR REPRODUCE THE ISSUE DURING IN-HOUSE TESTING FOR THE GCC. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE GCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN THE GOLDEN SYSTEM WAS SET TO RUN VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, NO ERROR COULD BE IDENTIFIED. VIDEO TEST PASSED. AS A RESULT OF THESE FINDINGS, FA CONCLUDE THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT RIGHT EYE VISION RESOLUTION WAS INCORRECT, AND THE TSE SUGGESTED HARD POWER CYCLE. THE ISSUE WAS NOT RESOLVED AFTER COUPLE OF HARD POWER CYCLE. THE RIGHT EYE VISION WAS COMPLETELY BLANK AND 45308 REPORTED EVERY POWER CYCLE. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412691 DAVINCI SI SURGEON SIDE CONSOLE, RECERTIFIED NAY INTUITIVE SURGICAL, INC 380689-02 N/A 00886874110782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES