BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 22899278 · Received August 26, 2025

    Report

    Report Number
    2955842-2025-35577
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 6, 2025
    Report Date
    November 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. SEVERAL ERBE ERRORS (M-26, M-11, M-10, M-12, M-02) WERE CONFIRMED IN THE LOGS. THE ERBE WAS TESTED USING THE SYSTEM, AND ERROR M-B0-60 SHOWED UP WHEN TESTING MONOPOLAR. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF ERROR M-36 IS ATTRIBUTED TO INSTALLATION ISSUES PREVENTING ENERGY ACTIVATION, AND M-11 INDICATES A CPU AND SENSORS MODULE INTERNAL TIME OUT. THE INSTRUMENT MAY BE INSTALLED ON THE PATIENT SIDE CART ARM, BUT THE ENERGY CORD MAY NOT BE PROPERLY CONNECTED TO THE INSTRUMENT AND/OR GENERATOR. THIS ERROR CAN BE RESOLVED THROUGH TROUBLESHOOTING OR REPLACEMENT OF THE GENERATOR.

    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 IS ATTRIBUTED TO A DEFECTIVE IESU. THE FSE REPLACED THE PART TO RESOLVE THE ISSUE.

    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 WAS NOT WORKING. THE CUSTOMER WAS GUIDED TO INSTALL AN EXTERNAL GENERATOR TO PROCEED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406554 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-09 N/A 00886874115343

    Patients

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