BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24693058 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18588
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 4, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE DISTAL SET UP JOINT (SUJ) WAS ANALYZED AND FOUND IN SYSTEM LOGS, ERRORS 23210 WAS FOUND INDICATING A HIGH-SIDE SWITCH STARTUP TEST FAILED ON UNIVERSAL SURGICAL MANIPULATOR (USM)3 POINTS TO AXES CONTROLLER SETUP (ACU)/ACJ IN PROXIMAL (SET UP JOINT) SUJ DUE TO MOTOR HSSW VOLTAGE. UPON VISUAL INSPECTION NO ISSUES WERE FOUND WHICH WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE NO ERRORS WERE FOUND AND THE UNIT FUNCTIONED AS EXPECTED. TESTED THE DISTAL ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL RELEVANT TESTING. ISI RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND IN SYSTEM LOGS, THE 23007 ERROR WAS FOUND INDICATING HIGH COMMAND VELOCITY DURING WIGGLE TEST ON THE 0X3 AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A PFTP WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) PRINTED CIRCUIT ASSEMBLY (PCA) WAS FURTHER INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. THE COMPLAINT REGARDING INSERTION AXES COULD NOT MOVE WAS CONFIRMED BY FAILURE ANALYSIS. WHILE THE DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED AS FAILURE ANALYSIS COULD NOT REPLICATE THE REPORTED ISSUE, POSSIBLE CAUSES INCLUDE ELECTRONIC DEFECTS OF THE AXES CONTROLLER TORNADO (ACT) TO SETUP FRU LOWER (SFL) CABLE ASSEMBLIES IN THE DSUJ AND THE INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) PRINTED CIRCUIT ASSEMBLY (PCA) IN THE USM.

    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 UNIVERSAL SURGICAL MANIPULATOR (USM) AND DISTAL SET UP JOINT (SUJ) TO CORRECT THE REPORTED ERROR. 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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3'S INSERTION AXIS COULD NOT MOVE. THE CALLER PERFORMED AN EMERGENCY POWER OFF OF THE PATIENT SIDE CART (PSC) AND EXERCISED THE USM, HOWEVER IT STILL FAILED TO COMPLETE HOMING. THERE WAS AN OBSTRUCTION MESSAGE AS WELL. THE CALLER ENSURED THE USM WAS FREE, AND EXERCISED IT MULTIPLE TIMES, WITH NO CHANGE. THE SURGEON ABORTED THE CASE TO ANOTHER SYSTEM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269195 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1