BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24631928 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16726
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 28, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE IESU FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE GENERATOR WAS ANALYZED AND FOUND TO REPORTED ISSUE WAS CONFIRMED USING SYSTEM LOGS, WITH C-34 ERRORS LOGGED, ALONG WITH RELATED C-38/C-37 AND M-11/M-18 ERRORS RECORDED. M-32 ERRORS WERE ALSO NOTED IN SYSTEM LOGS. DURING FAILURE ANALYSIS, LOG REVIEW IDENTIFIED C-00 AND M-11 ERRORS, CONFIRMING THE REPORTED EVENT; HOWEVER, THE ISSUE COULD NOT BE REPLICATED ONSITE. FUNCTIONAL TESTING ON THE SYSTEM SHOWED NO ERRORS, AND ALL OPERATIONS ACROSS ALL PORTS WERE SUCCESSFUL. ADDITIONAL M-31 ERRORS WERE OBSERVED IN THE LOGS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE OF THIS ISSUE IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT INTEGRATED ELECTROSURGICAL UNIT (IESU) FAILED TO DELIVER ENERGY. THE TSE FOUND ERRORS 25913 AND C-34 IN THE LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE GENERATOR. THERE WERE MULTIPLE ISSUES WITH SYSTEM GOING IN AND OUT WITH POWER/ENERGY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450776 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-18 N/A

    Patients

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