BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24317975 · Received February 11, 2026

    Report

    Report Number
    2955842-2026-04097
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 11, 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MASTER TOOL MANIPULATOR (MTM) WAS ANALYZED AND FOUND TO AND WHEN INSTALLED ON AN IN-HOUSE SYSTEM THE ERROR WAS TRIGGERED POINTING TO AXIS 3 (ELBOW). THE MTM ALSO FAILED THE POWER UP TEST ON AXIS 3 WHEN INSTALLED ON A TEST FIXTURE. THE COUNTERBALANCE SPRING CABLE WAS FURTHER TESTED AND CONFIRMED TO BE SOURCE OF THE FAULT. THE COMPLAINT REGARDING ERROR 23030 WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS DUE TO AN ISSUE WITH THE AXIS 3 COUNTERBALANCE SPRING CABLE.

    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) TO CORRECT THE REPORTED PROBLEM. 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; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE WITH A DUAL CONSOLE SETUP, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT MASTER TOOL MANIPULATOR LEFT (MTML) ON SURGEON SIDE CONSOLE (SSC) #1 DROPPED. THE TSE FOUND ERROR 23030 IN THE LOGS POINTING TO THE MTML. THE TSE ALSO FOUND THAT THE CUSTOMER DISABLED MTML AND CONTINUE THE PROCEDURE WITH THE OTHER SSC. THE TSE ADVISED THE CUSTOMER TO PERFORM HARD POWER CYCLE THE SSC AND TO REENABLE THE MTML AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627897 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-28 N/A 00886874110744

    Patients

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