BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24186384 · Received January 27, 2026

    Report

    Report Number
    2955842-2026-02263
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 16, 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
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND THE UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE DURING IN-HOUSE TESTING. HOWEVER, A REVIEW OF THE INTERNAL ERBE ERROR LOG SHOWED ERROR M-02, M-B0, C-00 AND M-B1. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    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 THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT YET RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT OF THE ERBE GENERATOR. M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED. THIS ERROR CAN BE RESOLVED AFTER POWER CYCLING THE GENERATOR AND/OR CHECKING THE CABLE CONNECTION TO THE SYSTEM. IN SOME CASES, THE AFFECTED COMPONENT MAY NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR.

    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 ERBE GAVE ERROR M-02. TROUBLESHOOTING, INCLUDING REBOOTING THE INTEGRATED ELECTROSURGICAL UNIT (IESU), REPLACING THE MONOPOLAR AND BIPOLAR CABLES, REPLACING THE INSTRUMENT, DISCONNECTING THE PEDALS, AND REPLACING THE ERBE FOR A BACKUP GENERATOR WERE RECOMMENDED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE GENERATOR WAS REPLACED WITH A FT10 TO CONTINUE WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40589 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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