BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25011161 · Received April 28, 2026

    Report

    Report Number
    2955842-2026-23001
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. THE UNIT WAS ANALYZED AND REVIEW REVEALED ERRORS M-11, M-18 AND C-06 ON 03/04/2026. FUNCTIONAL TESTING REVEALED THAT TH UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE. HOWEVER, A REVIEW OF THE INTERNAL ERBE ERROR LOG SHOWED ERRORS M-31, M-11, C-00, M-0B, M-1C AND M-B0.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ISSUES FIRING THE MONOPOLAR ENERGY AS AN ERROR M-11 OCCURRED ON THE ERBE GENERATOR. THE CUSTOMER CHANGED THE INSTRUMENT AND THE ISSUE RESOLVED FOR A SHORT TIME BUT THEN RETURNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAD ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE MONOPOLAR ENERGY CABLES AND RESTART THE ERBE. THE CUSTOMER WAS ABLE TO COMPLETE THE CASE WITH THE ERBE BUT HAD INTERMITTENT MALFUNCTIONS. THE ISSUE RESULTED IN A FIVE-MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443657 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES