BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22486741 · Received July 11, 2025

    Report

    Report Number
    2955842-2025-29491
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 28, 2025
    Report Date
    June 28, 2025
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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) MONITOR AND PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE HRSV MONITOR AND PMSC.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR AND THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WERE ANALYZED HAVING THE FOLLOWING FINDINGS: UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITOR WAS INSTALLED ON OUR PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM AND STARTED UP WITHOUT ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. THE SYSTEM IDLED FOR ONE HOUR AND VISUALLY VERIFIED THAT THERE WERE NO ISSUES. THIS UNIT WAS RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR ADDITIONAL TESTING AND POTENTIAL REPAIR. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) HAS A VISUAL INSPECTION PERFORMED AND NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED ISSUE. THE UNIT WAS INSTALLED ONTO THE KNOWN GOOD SYSTEM AND COMPLETED PROGRAM WITH NO PROBLEMS, CONTINUED PERFORMANCE WAS SET TO 10 POWER CYCLES AND SAT IDLE FOR ONE HOUR. AFTER TESTING 10 CYCLES, NO ERRORS WERE FOUND; THE IMAGE WAS GOOD. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS FOUND NO DAMAGE AND NO FUNCTIONAL ISSUE THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PRODUCTS WERE VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. A ROOT CAUSE COULD POSSIBLY BE RELATED TO AN ELECTRICAL COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RIGHT EYE ON THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) HAD NO IMAGE. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS BUT FOUND NO RELATED ERRORS. THE CUSTOMER RESTARTED THE SYSTEM, BUT THE ISSUE REMAINED. THE CUSTOMER CONFIRMED THAT THE VISION SIDE CART (VSC) IMAGE WAS WORKING PROPERLY. THE CUSTOMER NOTED THAT THE PROCEDURE COULD NOT CONTINUE WITH 2D VISION. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE SYSTEM HAD INITIALLY POWERED ON WITHOUT ANY ERRORS OR FUNCTIONAL ISSUES. THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820124 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-26 N/A 00886874110744

    Patients

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