BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21482728 · Received February 27, 2025

    Report

    Report Number
    2955842-2025-02355
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 29, 2025
    Report Date
    January 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MTM WAS INSTALLED ONTO A PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE SINE CYCLE WAS FOUND TO BE FAILING ON THE AXIS 1. ONCE TESTING WAS COMPLETED, THE AXIS 1 MOTOR AND MOTOR CABLE WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. ROOT CAUSE IS ATTRIBUTED TO AXIS 1 MOTOR AND AXIS 1 MOTOR CABLE.

    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. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). 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. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    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 NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SURGEON'S LEFT MASTER TOOL MANIPULATOR (MTML) WAS NOT WORKING. THE TSE REVIEWED THE SYSTEM LOGS AND THERE WERE NO ASSOCIATED LOGS TO REPORT. THE TSE WAS ABLE TO CONFIRM THE ISSUES AFTER SPEAKING WITH THE SURGEON. THE SURGEON REPORTED THAT THE MTML ON SURGEON SIDE CONSOLE (SSC) 2 (SERIAL #: (B)(6)) JUMPED AFTER PASSING THE CENTERLINE. IT ONLY JUMPED WHEN MOVING LEFT TO RIGHT AND THERE WERE NO ISSUES MOVING TOP TO BOTTOM. THE SURGEON REPORTED THAT IT FELT LIKE THE GEARS WERE SKIPPING INTERNALLY. THE SURGEON ALSO ADDED THAT THEY DID NOT HAVE AN INSTRUMENT COLLISION AS THE SECOND SCC'S MTML FEELS FINE AND IT WAS ONLY FELT ON SSC 2. THE CUSTOMER WAS PROCEEDING WITH THE CASE AND REQUESTED THE FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP TO CHECK THE SYSTEM. ALL AVAILABLE INFORMATION WAS COLLECTED AND THE CALL ENDED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON REPORTED THAT ONE OF THE TWO ARMS ON THE CONSOLE WAS NOT WORKING. THE SURGEON EXPLAINED THAT IT FELT AS THOUGH THERE WAS AN EXTERNAL COLLISION ON THE LEFT-HAND PIECE REGARDLESS OF WHICH INSTRUMENT IT WAS CONTROLLING. WHEN THE SURGEON SWITCHED TO THE OTHER CONSOLE THE PROBLEM WENT AWAY. THE SURGEON TRIED TURNING IT OFF AND ON AND IT DID NOT FIX THE PROBLEM. THE SURGEON DID NOT KNOW IF THE ISSUE HAD BEEN CORRECTED OR NOT AS THEY HAD NOT OPERATED THERE AGAIN SINCE THE EVENT. THE SURGEON CONFIRMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SSC HIGH RESOLUTION STEREO VIEWER AND THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THE SURGEON CLARIFIED THAT THE ISSUE WAS THAT THE MTM HAD RESISTANCE AND IT MOVED WITH FRICTION THAT WAS UNSTEADY. THERE WAS NO PATIENT INJURY OR TISSUE INJURY AS A RESULT OF THE ISSUE. THE MTM WAS NOT ABLE TO BE USED AND THE SURGEON SWITCHED TO THE OTHER CONSOLE. THE SURGEON CONFIRMED THAT THE PROCEDURE WAS COMPLETED BECAUSE THEY HAD ANOTHER CONSOLE. THE SURGEON EXPRESSED THAT WITHOUT IT, IT WOULD HAVE FELT VERY DIFFICULT OR NOT SAFE. NO PATIENT DEMOGRAPHICS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029957 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A

    Patients

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