BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20629079 · Received November 7, 2024

    Report

    Report Number
    2955842-2024-21642
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED VIA A VIDEO ATTACHMENT BUT NOT REPLICATED IN-HOUSE. IN THE VIDEO, THE ARM CAN BE SEEN OSCILLATING ALONG 2 POINTS ON THE PITCH AXIS ¿EVEN THOUGH THE MASTER ARM WAS NOT BEING OPERATED.¿ THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM WHERE IT PASSED NORMAL MODE WITH NO RELATED ERRORS. A HARD SHELL ABDOMEN MODEL WAS USE TO ATTEMPT TO REPLICATE THE OSCILLATING MOTION BUT DID NOT. THE UNIT WAS ALSO TESTED ON AN IN-HOUSE PFTP WHERE IT PASSED ALL TESTS WITH NO RELATED ERRORS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    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 SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) MOVED WITH NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON'S HEAD WAS INSIDE THE HIGH RESOLUTION STEREO VIEWER ATTEMPTING TO MANIPULATE INSTRUMENTS WHEN THE ISSUE OCCURRED. THE CUSTOMER WAS ABLE TO REACH A CERTAIN ANGLE DURING A MOVEMENT AND THEN THE INSTRUMENT STARTS TO MOVE ON ITS OWN. THE INSTRUMENT MOVED IN THE INTENDED DIRECTION WHEN THE ANGLE WAS NOT APPROPRIATE. IF THE ANGLE WAS APPROPRIATE THEN IT COULD CONTINUE. THE INSTRUMENT WAS OBSERVED TO HAVE A RECIPROCATING MOTION. THE TIMING OF THE MOVEMENT WAS APPROPRIATE WHEN IT WORKED NORMALLY. THE ARM WAS SHAKING, BUT THE CUSTOMER WAS UNSURE ABOUT FRICTION AS THE PATIENT HAD A VERY STIFF CHEST WALL. THERE WAS NO INSTRUMENT TO INSTRUMENT INTERFERENCE AND NO EXTERNAL COLLISIONS. THE ISSUE WAS INTERMITTENT AND ONLY OCCURRED AT CERTAIN ANGLES. THE SURGEON FOUND AN ANGLE WHERE THE ISSUE DID NOT OCCUR AND CONTINUED THE OPERATION TO AVOID THE ANGLES WHERE THE INSTRUMENT MOVED ON ITS OWN. THE INSTRUMENT YAW MOVED UP AND DOWN AT A STEADY PACE WHEN AT A CERTAIN ANGLE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46717 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES