BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22788630 · Received August 12, 2025

    Report

    Report Number
    2955842-2025-33650
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 15, 2025
    Report Date
    November 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    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 INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE MTM HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. .

    Additional Manufacturer Narrative · 0

    CORRECTION TO H8 FIELD - UPDATED TO INITIAL USE OF DEVICE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MASTER TOOL MANIPULATOR (MTM) TO PERFORM FAILURE ANALYSIS (FA). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM BOOTED UP FINE AND PASSED ALL TESTS BUT WAS NOT IN THE PROPER HOMING POSITION. THE MTM WAS INSTALLED ONTO A PSC (PATIENT SIDE CART) FIXTURE TEST PLATFORM (PFTP) SYSTEM WHERE ALL TESTS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED THE MTM WAS INSPECTED BUT NO FAULTS COULD BE IDENTIFIED. THE COMPLAINT WAS CONFIRMED BASED ON FA. THE ROOT CAUSE IS ATTRIBUTED TO CALIBRATION OF THE MTM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTIES MOVING THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND NOTED AN INADVERTENT MOVEMENT. THE CUSTOMER REPORTED THE ISSUE POST THE PROCEDURE COMPLETION. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO ENSURE THAT THE DRAPE WAS NOT OBSTRUCTING THE USM MOVEMENT FOR THE NEXT PROCEDURE. THE CUSTOMER CALLED BACK DURING THE NEXT PROCEDURE AND REPORTED THAT THE RESISTANCE ISSUE CONTINUED ON THE USM 4. THE SURGEON ALSO NOTED THAT RESISTANCE WAS FELT ON THE MASTER TOOL MANIPULATOR (MTM) CONTROLLING THE USM 4. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER BELIEVED IT WAS THE SURGEON¿S CONSOLE RIGHT ARM. BASICALLY, WHEN THE SURGEON LET GO, THE HANDPIECE MOVED DOWN AND OPENED AND IT WANTED TO DO THIS MOVEMENT THE WHOLE TIME WHICH WAS A BIT IRRITATING BECAUSE THE MOVEMENT NEEDED COUNTERING TO STOP. IT WAS INTERFERING WITH THE OPERATION. THIS OCCURRED WITH THE SURGEON'S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER AND WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE THE INSTRUMENT FROM THE SURGEON CONSOLE. THE ISSUE WAS PERSISTENT AND WAS FIXED BY THE FIELD SERVICE ENGINEER THE NEXT DAY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271734 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A 00886874110744

    Patients

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