BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24385627 · Received February 19, 2026

    Report

    Report Number
    2955842-2026-04890
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 3, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS LINKED TO THE CONSOLE BUT UNABLE TO BE TRACED MORE SPECIFICALLY AS FAILURE ANALYSIS WAS ABLE TO CONCLUDE THE COMMON COMPUTER CONTROLLER (CCC) BOARD WAS FUNCTIONING AS EXPECTED.

    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. WHILE ONSITE, THE FSE VERIFIED THAT THE POWER CABLE HAD NO ISSUES. THE FSE THEN REPLACED AND VERIFIED THE MEDICAL GRADE POWER SUPPLY (MGPS), BUT THE ISSUE REMAINED. THE FSE REPLACED THE SECOND MGPS, AND THE ISSUE PERSISTED. THE FSE REINSTALLED THE ORIGINAL MGPS IN ALL ORIGINAL LOCATIONS. THE FSE VERIFIED THAT ALL THE CABLES WERE NOT DAMAGED. THE FSE THEN REPLACED THE SURGEON SIDE CONSOLE (SSC) COMMON COMPUTER CONTROLLER (CCC). AFTER REPLACING THE CCC, THE SYSTEM POWERED UP WITHOUT ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM A FAILURE ANALYSIS INVESTIGATION. THE INVESTIGATION REVEALED THAT THE ISSUE WAS UNRELATED TO THE SSC CCC. LIGHTHOUSE LOG REVIEW SHOWED THAT, EVEN AFTER REPLACING THE SSC CCC, THE FAILURE PERSISTED, CONFIRMING THAT THE PROBLEM WAS ASSOCIATED WITH A DIFFERENT COMPONENT. THEREFORE, THE REPORTED FAILURE COULD NOT BE CONFIRMED OR REPLICATED DURING TESTING OF THE SSC CCC. IN LIGHTHOUSE, NO DATA INDICATED THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. THE SSC CCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE FIBER OPTIC LIGHT LEVELS ON THE CCC WERE INSPECTED, AND ALL VALUES WERE WITHIN EXPECTATION. TEN POWER CYCLES WERE PERFORMED, AND THE CCC WAS LEFT IN THE GOLDEN SYSTEM TO IDLE FOR 1 HOUR WITH NO ISSUES FOUND. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THE REPORTED EVENTS.

    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 SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SECONDARY SURGEON SIDE CONSOLE (SSC) WAS NOT POWERING ON AND WAS NON-FUNCTIONAL. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO CYCLE THE BREAKER ON THE SSC AND TO MOVE POWER CORDS WHEN IT WAS CLINICALLY POSSIBLE, AS TAKING ACTION IMMEDIATELY COULD RESULT IN A NON-RECOVERABLE FAULT ON THE SYSTEM. THE SITE INDICATED THAT THEY WOULD TROUBLESHOOT THE ISSUE AFTER THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OPERATION ROOM STAFF SAID THAT THE SECONDARY SURGEON CONSOLE WAS NOT USED AT ALL FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218260 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

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