BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24710162 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19181
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 14, 2025
    Report Date
    March 26, 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
    FL, 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 REPLACED THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE UNIT WAS ANALYZED, AND UPON VISUAL INSPECTION, THE UNIT WAS FOUND TO HAVE DENTS AND SCUFFS ON THE BEZEL, DISCOLORATION ON THE HEATSINK, AND POINTS OF TOUCH-UP PAINT ON THE HOUSING/COVERING. THE REPORTED PROBLEM WAS ABLE TO BE CONFIRMED IN THE SYSTEM LOGS WHERE THE U-02 ERROR WAS RECORDED ON 14-NOVEMBER-2025. THE ERBE WAS TESTED ON AN IN-HOUSE SYSTEM AND THE UNIT DISPLAYED MULTIPLE ERRORS OF U-02 UPON STARTUP AND REMAINED ON INTUITIVE SPLASH SCREEN. THE U-02 CONDITION PREVENTED ACCESS TO ERBE LOGS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT AN "ACTIVATION HAS BEEN INTERRUPTED" MESSAGE ON THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO AN U-02 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE ERROR LOGS AND IDENTIFIED THE U-02 ERROR. THE TSE WALKED THE CUSTOMER THROUGH A TWO (2) MINUTE HARD POWER CYCLE OF THE ERBE UNIT WITH NO CHANGE. THE CUSTOMER NOTED THAT THEY MAY PERFORM THE PROCEDURE LAPAROSCOPICALLY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143062 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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