BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24916714 · Received April 17, 2026

    Report

    Report Number
    2955842-2026-22095
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 17, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 CONFIRMED ENCODER ISSUE ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND REPLACED USM 2 TO RESOLVE 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. THE USM WAS ANALYZED AND FOUND TO FAIL TESTS WHEN TESTING ON AN IN-HOUSE SYSTEM. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. 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 IS ATTRIBUTED TO SENSOR ERRORS OF YAW SEARCHLIGHT PRINTED CIRCUIT ASSEMBLY (PCA) AND YAW FLAT FLEX CABLE (FFC). IT CAN BE RESOLVED BY REPLACING USM ARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERRORS OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE TSE CONFIRMED THE ERRORS IN THE LOGS POINTING TO USM 2 AXES CONTROLLER, ARM (ACA). THE TSE HAD THE CUSTOMER DISABLE USM 2, AND THE SYSTEM WAS ABLE TO COMPLETE THE SELF-TEST AND HAD NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581442 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

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