BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22143993 · Received June 4, 2025

    Report

    Report Number
    2955842-2025-23323
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 13, 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
    JA
    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 MASTER TOOL MANIPULATOR (MTM) DUE TO REPEATED 23013 ERROR CODE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE MTM FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MASTER TOOL MANIPULATOR (MTM2) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED PROBLEM "ERROR 23013 POINTING TO MTMR" WAS CONFIRMED AND REPLICATED. IN SYSTEM LOGS, THE 23013 ERROR WAS FOUND INDICATING THE POT AND ENCODER ARE NOT TRACKING EACH OTHER PROPERLY ON THE MTM AXIS 3. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE NO TESTS COULD BE RUN. THE AXIS 3 MOTOR AND MOTOR CABLE WERE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT WHICH IS ATTRIBUTED TO AN ELECTRICAL COMPONENT FAILURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS' ADDITIONAL INVESTIGATION FOUND THE MASTER TOOL MANIPULATOR¿S (MTM2) TENSIONED CABLE ON AXIS 2 TO BE UNWRAPPED AND DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ERROR 23013 HAD OCCURRED. THE TSE FOUND ERRORS 23013 AND 23008 POINTING TO RIGHT MASTER TOOL MANIPULATOR (MTMR) AXIS 3 IN THE LOGS. THE CUSTOMER HAD HARD POWER CYCLED THE SURGEON SIDE CONSOLE (SSC) TWICE, BUT THE ERROR PERSISTED. THE CUSTOMER DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND POWERED UP WITH NO ERRORS. THE PORTS INCISIONS WERE NOT INCREASED, AND THE PATIENT TOLERATED THE CONVERSION. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588878 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

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