BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22918909 · Received August 28, 2025

    Report

    Report Number
    2955842-2025-36079
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 11, 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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND A REVIEW OF THE LOGS REVEALED ERROR M-02, M-B1 AND C-83, C-71, C-82. UPON VISUAL INSPECTION, THERE WERE NO ISSUES FOUND THAT WOULD RELATE TO THE REPORTED PROBLEM. THE ERBE WAS TESTED USING THE SYSTEM; ALL OPERATIONS WERE SUCCESSFUL, ALL PORTS WERE OPERATIONAL, AND ALL INSTRUMENTS WERE RECOGNIZED. THE ERBE WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT OF THE ERBE GENERATOR. M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED. THIS ERROR CAN BE RESOLVED AFTER POWER CYCLING THE GENERATOR AND/OR CHECKING THE CABLE CONNECTION TO THE SYSTEM. IN SOME CASES, THE AFFECTED COMPONENT MAY NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE.

    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THERE WAS AN ERROR DURING THE USE OF BIPOLAR INSTRUMENTS. THE USER HAD TESTED BIPOLAR FUNCTIONALITY IN BOTH PORTS ON THE ERBE AND REPLACED THE BIPOLAR CABLE WITH A NEW ONE, BUT THE ISSUE PERSISTED. THE USER ALSO RESTARTED THE ERBE, BUT THE PROBLEM CONTINUED. DURING THE PROCEDURE, THE SITE USED AN EXTERNAL GENERATOR WITH THE SAME BIPOLAR INSTRUMENT TO COMPLETE THE SURGERY. THE TSE REVIEWED THE SYSTEM ERROR LOGS AND CONFIRMED ERROR CODES INDICATING A MODULE TIMEOUT AND ACTIVATION HALT FOR BIPOLAR OPERATION. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248062 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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