BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24124140 · Received January 20, 2026

    Report

    Report Number
    2955842-2026-01709
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 26, 2026
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 THE 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 PMSC. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED AND REPLICATED. IN THE SYSTEM LOGS, THE ERROR 48200 WAS FOUND INDICATING A COMMUNICATION FAULT FROM THE PMSC, CONFIRMING THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION REVEALED NO ANOMALIES RELATED TO THE REPORTED ISSUE. WHEN INSTALLED ON A GOLDEN SYSTEM, THE UNIT FAILED AT POWER-UP WITH ERROR CODE 48200, AND LEAF 3 WAS NOT DISPLAYED IN THE LAPTOP APPLICATION. BASED ON THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE SURGEON CONSOLE LEAF (SCL)-1 BOARD WAS THE SOURCE OF THE REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL ISSUES RESULTED FROM A FAULTY SCL-1 BOARD LOCATED ON PMSC. THIS ISSUE CAN BE RESOLVED BY REPLACING THE PMSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT HIGH-RESOLUTION STEREO VIEWER (HRSV) LOST ONE EYE VIDEO IMAGE. THE CUSTOMER WAS NOT SURE WHICH HRSV HAD THE ISSUE. THE CUSTOMER CONTINUED THE PROCEDURE WITH DUAL CONSOLE CONFIGURATION AND COULD NOT TROUBLESHOOT AT THE TIME OF THE PHONE CALL. THE TSE ADVISED THE CUSTOMER TO POWER CYCLE THE SYSTEM TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184608 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-30 N/A 00886874110744

    Patients

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