BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 23698519 · Received December 2, 2025

    Report

    Report Number
    2955842-2025-47135
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 11, 2025
    Report Date
    March 5, 2026
    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
    GM
    Reporter Occupation
    NURSE
    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 INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS DID NOT REPLICATE BUT CONFIRMED THE COMPLAINT ERROR C-38. IN ERROR LOG, THE C-00 ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE GENERATOR FUNCTIONED AS EXPECTED. THE IESU ENERGIZED AND CAUTERIZED AND ALL PORT RECOGNIZED INSTRUMENTS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA-VINCI ASSISTED RADICAL PROSTATECTOMY (WITH LYMPHADENECTOMY) THE CUSTOMER CALLED IN TO REPORT THE FOLLOWING PROBLEM: ERROR C-38 ON THE ERBE GENERATOR. THE INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE ERROR LOGS, VERIFIED THE FAULT AND ASKED THE CUSTOMER IF THE ERBE GENERATOR WAS ALREADY RESTARTED: THE CUSTOMER DID RESTART ALREADY SEVERAL TIMES. CHANGING THE CABLE DID NOT HELP. USING THE SECOND MONOPOLAR OUTLET ALSO DID NOT HELP. CUSTOMER HAD NO VALLEYLAB INTEGRATED ELECTROSURGICAL UNIT (IESU) AND NO SECOND DA VINCI AVAILABLE. SINCE BOTH MONOPOLAR AND BIPOLAR ENERGY WORKED, THE CUSTOMER COULD WORK WITH THE SYSTEM AFTER ACKNOWLEDGING THE WARNING MESSAGE. THE INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) ALSO TOLD THE CUSTOMER TO BE PREPARED THAT THE PROBLEM COULD COME BACK EVERY TIME. AT ONE POINT CUSTOMER COULD NOT ACTIVATE MONOPOLAR CUT FUNCTION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112870 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-10 N/A 00886874115343

    Patients

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