BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23722220 · Received December 4, 2025

    Report

    Report Number
    2955842-2025-47520
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 4, 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
    MO, US
    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 DUE TO INTERMITTENT BIPOLAR ENERGY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ISSUE WAS NOT ABLE TO BE CONFIRMED USING SYSTEM LOGS, BUT 1-8A AND M-11 ERRORS WERE FOUND IN THE LOGS AND MAY BE RELATED. AN INSPECTION DURING FA PROCESS WAS UNABLE TO FIND ISSUES WHICH MAY BE RELATED TO THE REPORTED EVENT. THE C-84 ERRORS IN ERBE LOGS MAY BE RELATED, BUT UNCONFIRMABLE. THE UNIT WAS TESTED ON SYSTEM, AND ALL INSTRUMENT RECOGNITION AND ENERGY OPERATION TESTS WERE PERFORMED SUCCESSFULLY ON ALL PORTS. THE ERBE WILL BE SENT TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION OR FAILURE ANALYSIS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT INTERMITTENT BIPOLAR ENERGY WAS OBSERVED DURING A CASE, ALTHOUGH NO ERROR MESSAGES WERE DISPLAYED. THE SITE STAFF HAD ALREADY ATTEMPTED TO RESOLVE THE ISSUE PRIOR TO CONTACTING TSE BY TRYING ANOTHER ENERGY CABLE, INSTRUMENT, AND BOTH BIPOLAR PORTS, BUT THE PROBLEM PERSISTED. IT WAS MENTIONED THAT THIS HAD BEEN AN INTERMITTENT ISSUE FOR ABOUT A WEEK. TSE INQUIRED IF THE STAFF TRACKED THE LIFESPANS OF ENERGY CABLES AND WAS INFORMED, THEY DID NOT. TSE RECOMMENDED REBOOTING THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE OR TRYING A BRAND-NEW BIPOLAR ENERGY CABLE. NO RELATED ERRORS WERE FOUND IN THE SYSTEM LOGS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156832 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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