BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23364707 · Received October 23, 2025

    Report

    Report Number
    2955842-2025-42614
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 1, 2025
    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
    NY, US
    Reporter Occupation
    NURSE
    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. THE FSE REPLACED THE AFFECTED MASTER TOOL MANIPULATOR (MTM) TO RESOLVED THE 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. UPON VISUAL INSPECTION, THE MTM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR WAS TRIGGERED INDICATING FAULT ON THE AXIS 1, REPLICATING THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A SURGEON SIDE CONSOLE FIXTURE TEST PLATFORM (SFTP) WHERE POWER UP WAS FOUND TO BE FAILING ON AXIS 1. ONCE TESTING WAS COMPLETED, THE AXIS 1 MOTOR WAS FURTHER TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE CAN BE ATTRIBUTED TO A FAULT OF AN ELECTRONIC COMPONENT OR MODULE WITHIN THE AXIS 1 MOTOR OF THE AFFECTED MTM. THIS ISSUE CAN BE RESOLVED BY REPLACING THE AFFECTED MTM VIA FSE SERVICE OR SWITCHING TO A DIFFERENT SURGEON SIDE CONSOLE (SSC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR WITH MESH SURGICAL PROCEDURE, AN OPERATING ROOM (OR) STAFF CALLED IN TO REPORT THAT THE SECOND SURGEON SIDE CONSOLE (SSC) RIGHT MASTER TOOL MANIPULATOR (MTMR) DROPPED DURING USE. THE SITE RESTARTED THE SYSTEM, BUT THE MTMR DID NOT COME UP. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND REPEATED POT TO ENCODER FAULTS ON AXIS 4 OF THE MTMR. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MTMR BECAME NON-FUNCTIONAL, FAILING TO RESPOND DURING THE PROCEDURE. TO RESOLVE THIS ISSUE AND CONTINUE THE SURGERY, THE CUSTOMER UTILIZED THE OTHER SSC, ALLOWING THE CASE TO PROCEED. THE PROCEDURE WAS INITIATED WITH A DUAL CONSOLE SETUP AND ULTIMATELY COMPLETED WITH ONE SSC AFTER DISABLING THE DEFECTIVE MANIPULATOR. THE PRIMARY PROBLEM WAS THAT THE AFFECTED MANIPULATOR DID NOT MOVE AT ALL, RENDERING IT UNRESPONSIVE TO THE SURGEON'S COMMANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727465 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES