BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694172 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17949
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    April 25, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. FSE REPLACED PMSC REPLACED TO CORRECT ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED AND THE REPORTED VISION FAILURE ON LEFT EYE WAS CONFIRMED AND REPLICATED. IN REMOTEFE AND ARTEMIS, ERROR 48200 WAS FOUND INDICATING THE FAULT, CONFIRMING THE FAILURE OCCURRED IN THE FIELD. VISUAL INSPECTION REVEALED THAT NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE PMSC WAS INSTALLED ONTO A GOLDEN SYSTEM (IS 4200) WHERE THE ERROR 48200 WAS TRIGGERED BY INDICATING A FAULT ON THE SCL 1, REPLICATING THE REPORTED EVENT. THEN THE GOLDEN SYSTEM WAS SET TO RUN VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED AND VERIFIED IDENTIFYING THE LEAF 3 TO BE THE SOURCE OF THE FAULT.. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. AS A RESULT OF THIS FINDING, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT SURGEON CONSOLE LEAF (SCL) 1 ON THE PMSC WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE LEFT EYE IMAGE IS BLACK ON SURGEON SIDE CONSOLE (SSC)2. CUSTOMER HAD THE SAME ISSUE DURING THE FIRST SURGERY OF THE DAY. ANOTHER SR WILL BE CREATED TO REGISTER THIS COMPLAINT. PRIOR TO CALL TECHNICAL SUPPORT HE HAD ALREADY POWER CYCLE SYSTEM TWICE AND RESEATED BFC ON SSC WITHOUT IMPROVEMENT. TSE CHECKED LOGS AND FOUND THE ERROR 48200 POINTING TO PERSONALITY MODULE SURGEON CONSOLE (PMSC) FAILURE. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED CALLER TO CHECK IF SOMETHING IS CONNECTED TO THE BACK OF THE SSC. SURGEON FOUND A VIDEO CABLE CONNECTED. AFTER DISCONNECTED IT AND PERFORM POWER CYCLE LEFT EYE WAS STILL BLACK AND SURGEON GOT RECOVERABLE ERROR 48200. TSE INFORMED CALLER THAT A BOARD (PMSC) IN THE SSC DID NOT INITIALIZE WELL DURING STARTUP AND NEEDS TO BE REPLACED. SURGERY WILL BE PERFORMED WITH ONLY ONE SSC WITHOUT IMPACT FOR THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE HAS BEEN SUCCESSFULLY COMPLETED WITH THE SECOND SURGEON'S CONSOLE FULLY OPERATIONAL, THE ISSUE WAS IDENTIFIED AFTER ADMINISTRATION OF ANAESTHESIA, AND BEFORE PLACEMENT OF PORTS, THE FIRST SURGICAL PROCEDURE INITIALLY ENVISAGED WITH A DUAL SURGEON CONSOLE CONFIGURATION BUT WAS NOT COMPLETED WITH BOTH SURGEON CONSOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61982 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24

    Patients

    Seq Age Sex Outcome Treatment
    1