BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24032880 · Received January 12, 2026

    Report

    Report Number
    2955842-2026-01078
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 29, 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
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE A DEFINITIVE ROOT-CAUSE CANNOT BE ESTABLISHED SINCE THE REPORTED COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING, A POTENTIAL ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO COMMUNICATION FAILURES CAUSED BY INTERMITTENT FAILURES WITHIN THE INSERTION CHIPENCODER VIRTUAL ABSOLUTE BOARD OR BY FAULTY FLAT FLEX CABLE CONNECTIONS WITHIN THE UNIVERSAL SURGICAL MANIPULATOR 1.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS NOT ABLE TO REPRODUCE THE ISSUE; HOWEVER, THE FSE DID REPLACE THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE USM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE CHIPENCODER VIRTUAL ABSOLUTE (CVA), CVA DISK, FLAT FLEX CABLE (FFC) AND HALL SENSOR WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. .

    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 SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) THAT WHILE DRAPING THE SYSTEM THAT THE SYSTEM GAVE THEM A RECOVERABLE 23118 ERROR. TSE VIEWED SYSTEM LOGS AND NOTED 23118 ERROR POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) 1. TSE ADVISED THAT THE ERROR MAY OR MAY NOT RETURN. THEY ARE PROCEEDING WITH THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372105 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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