BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23119474 · Received September 23, 2025

    Report

    Report Number
    2955842-2025-38965
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 5, 2025
    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
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. 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 VIDEO PROCESSOR (VP). THE SYSTEM WAS VERIFIED AND READY FOR USE. THE VISION PROCESSOR (VP) WAS ANALYZED AND IN LOGS, ERROR 319 WAS FOUND INDICATING THAT THE FAULT HAD OCCURRED IN THE FIELD. VISUAL INSPECTION FOUND NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE VP WAS INSTALLED ONTO A GOLDEN SYSTEM (IS 4200) WHERE ERROR 319 WAS TRIGGERED INDICATING FAULT ON THE VP, 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 THE DWA TO BE THE SOURCE OF THE FAULT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO, BASED ON FINDINGS FROM FAILURE ANALYSIS, THE DWA (DUAL WINDOW APPLIANCE) BOARD ON THE VP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT NON-RECOVERABLE ERRORS OCCURRED DURING POWER-UP AFTER ATTEMPTING TO COMPLETELY POWER CYCLE THE VIDEO SYSTEM CONTROLLER. THE ERRORS WERE RELATED TO THE VIDEO PROCESSOR IN THE VIDEO SYSTEM CONTROLLER. A COMPLETE POWER CYCLE OF THE VIDEO PROCESSOR AND VISION TOWER WAS PERFORMED A SECOND TIME, BUT THE 319 ERRORS RELATED TO THE VIDEO PROCESSOR PERSISTED. THE PATIENT WAS ALREADY ON THE TABLE, AND THE PORTS HAD BEEN PLACED, SO THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941715 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A

    Patients

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