BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23844928 · Received December 18, 2025

    Report

    Report Number
    2955842-2025-49010
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 18, 2025
    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
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE INSPECTED THE SYSTEM AND NOTED THAT INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE WAS WORKING PROPERLY WITHOUT ERRORS. FSE REPLACED THE ERBE GENERATOR TO RESOLVE THE REPORTED ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE ERBE TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE COMPONENT WAS ANALYZED AND IT WAS FOUND TO HAVE ERROR M-02 ON SYSTEM LOGS. FURTHER SYSTEM TESTING SHOWED THAT THE UNIT DISPLAYED ERROR M-02-3 UPON STARTUP, WITH CORRESPONDING ERBE LOG ERRORS M-02, M-12, M-31 AND M-B0. UPON VISUAL INSPECTION, THE UNIT WAS FOUND TO HAVE LIGHT SCUFFS AND HAZING ON THE GREY BEZEL. THE PROBABLE ROOT CAUSE OF REPORTED EVENT IS ATTRIBUTED TO COMPONENT FAILURE CAUSING EBRE TO FAULT WITH MODULE TIMEOUT ERRORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE WAS FAULTING WITH ERROR. CUSTOMER TRIED RESTARTING THE UNIT BUT WITH NO CHANGE. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED CUSTOMER TO PERFORM ANOTHER RESTART ON THE GENERATOR AFTER IT HAD BEEN ON A WHILE AND ERROR CLEARED. CUSTOMER WAS CONTINUING WITH THE CASE. ON A FOLLOW-UP CALL, CUSTOMER STATED THAT THEY WERE STILL UNABLE TO USE THE MONOPOLAR ENERGY. CUSTOMER HAD TRIED A SECOND MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH, GOT REGISTERED TO THE SYSTEM ARM. TSE SUGGESTED TO USE ANOTHER INSTRUMENT AND/OR ANOTHER CABLE. THE ISSUE WAS LIKELY ASSOCIATED WITH ERBE GENERATOR. CUSTOMER HAD A PROCEDURE TO FOLLOW. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243888 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-10 00886874110898

    Patients

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