BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22352347 · Received June 27, 2025

    Report

    Report Number
    2955842-2025-27566
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 13, 2025
    Report Date
    January 30, 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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS ANALYZED. IN THE ERROR LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. HOWEVER, THE PROBABLE CAUSE IS LIKELY ATTRIBUTED A COMPONENT FAILURE DUE TO AN OPERATIONAL PROBLEM WITHIN THE ERBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CUT WAS ACTIVATED WITHOUT THE SURGEON PRESSING THE FOOT PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER STATED THAT THE INSTRUMENT WAS CONNECTED TO THE UPPER MONOPOLAR PORT OF THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE AT THE TIME. THE PROSTATECTOMY PROCEDURE WAS AT A STAGE WHERE MONOPOLAR WAS NO LONGER REQUIRED, LEADING TO THE REMOVAL OF THE INSTRUMENT AND CABLE FROM THE ERBE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT WHEN THE MONOPOLAR WAS ACTIVATED INDEPENDENTLY. THE INSTRUMENTS WERE AWAY FROM ANY TISSUE AT THE TIME.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814668 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