BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24692061 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17771
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 25, 2025
    Report Date
    March 25, 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
    NJ, US
    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 THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) DUE TO ERROR 45308. FSE SWAPPED THE DIGITAL VIDEO INTERFACE (DVI) CABLES TO VERIFY THAT BOTH THE MONITOR AND HARNESS WERE NOT CAUSING THE ISSUE. FSE THEN NOTICED THAT BOTH BLUE FIBER LEDS ON SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CONSOLE (VSC) WERE RED, FSE SWAPPED THE BLUE FIBER CABLE AND PORT ON THE VSC WITH NO RESOLUTION. FWE REPLACED THE BLUE FIBER PORT ON THE SSC AND THE ERROR CLEARED AND IMAGE IN BOTH EYES RETURNED. 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 PMSC WAS ANALYZED AND IN ARTEMIS, NO DATA FOUND TO INDICATE THE FAILURE OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, BOTH DVI PORTS ON VIDEO INPUT LEAF (VIL)S AND SURGEON CONSOLE LEAF (SCL)S WERE FOUND DAMAGED DUE TO WEAR AND TEAR. THE PMSC WAS INSTALLED ONTO THE GOLDEN SYSTEM, UPON THE POWER ON, THE SYSTEM FAILED WITH ERROR CODE 48200. LEAF 3 WAS NOT PRESENTED ON LAPTOP APP. 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 THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT DAMAGED OF BOTH SCLS WERE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE RIGHT EYE OF THE HIGH RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CONSOLE (SSC) WAS BLACK AND SHOWED AN HOURGLASS ICON. AFTER A HARD POWER CYCLE AND RESEATING ALL BLUE FIBER CABLES, THE ISSUE PERSISTED. CUSTOMER DECIDED TO REMOVE THE AFFECTED SSC AND PROCEED WITH SETUP USING A SINGLE-CONSOLE CONFIGURATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458739 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-21 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1