BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20917263 · Received December 12, 2024

    Report

    Report Number
    2955842-2024-23180
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 16, 2024
    Report Date
    November 17, 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
    WA, US
    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 STAFF INFORMED THE FSE THAT THE TORPEDO AXIS WAS NOT WORKING ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE FSE CONFIRMED THAT THE ISSUE WAS RELATED TO A FAULTY BUTTON AND REPLACED THE USM. ALL THE OTHER USMS WERE PASSING A DIAGNOSTIC TEST ENVIRONMENT (DTE) WORKFLOW. THE FSE ALSO IDENTIFIED AN UNRELATED ISSUE. THE PERSONALITY MODULE AUDIO/VIDEO (PMAV) HAD A BROKEN DIGITAL VIDEO INTERFACE (DVI) PORT IN THE VISION SIDE CART (VSC) AND WAS REPLACED, PROGRAMMED, AND TESTED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. THE PMAV HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE UNIT WAS RETURNED FOR BEING STICKY. FA WAS ABLE TO CONFIRM AND REPRODUCE THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM WHERE THE TORNADO UP AND DOWN SWITCH WAS SAID TO BE STICKY. THE UNIT WAS TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE THE TORNADO UP AND DOWN SWITCH WAS NOTED TO BE STICKY AS WELL. DURING VISUAL INSPECTION, FLUID INTRUSION WAS FOUND THROUGHOUT THE INSERTION SWITCH ASSEMBLY. THE INSERTION SWITCH ASSEMBLY WILL BE REPLACED BECAUSE FLUID INTRUSION WAS THE ROOT CAUSE OF THE REPORTED PROBLEM. THE PERSONALITY MODULE AUDIO/VIDEO (PMAV) HAS BEEN EVALUATED BY THE FA TEAM. FA WAS ABLE TO CONFIRM AND REPRODUCE THE REPORTED COMPLAINT. UPON VISUAL INSPECTION, FA FOUND DIGITAL VIDEO INTERFACE (DVI) PORTS ON VIDEO OUTPUT LEAF (VOL) 3 WAS DAMAGED WHICH ARE CAUSING THE REPORTED FAILURE. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT THE VOL 3 WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS STICKY. THE TSE REVIEWED THE LOGS AND THERE WERE NO ISSUES NOTED. THE CUSTOMER STATED THAT THE CARRIAGE ACTUALLY STOPPED FOR APPROXIMATELY 10-15 SECONDS BEFORE THE SURGEON COULD TAKE CONTROL AGAIN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE HAPPENED ON THE 3RD AND 4TH CASE THAT DAY. THE 3RD CASE (MFR REPORT NUMBER 2955842-2024-23056) WAS THE ONLY CASE WHERE THE INSTRUMENT WOULD GET STUCK, AND WHILE IT WAS STUCK THE INSTRUMENT COULD NOT UN-GRIP TISSUE. THE INSTRUMENT LET GO AFTER 15 SECONDS BEFORE THEY HAD TO USE THE INSTRUMENT RELEASE KEY. THERE WAS NO BLEEDING, NO EFFECT TO TISSUE AND NO HARM OR INJURY TO THE PATIENT. THE 4TH CASE ONLY HAD AN ISSUE WITH THE INSTRUMENT MOVING IN AND OUT ON ITS OWN. IT STILL WORKED SO THEY DID NOT HAVE TO REPLACE THE INSTRUMENT. THE CARRIAGE GOT STUCK, BUT THEY COMPLETED THE CASE ROBOTICALLY. THE USM DID NOT MOVE IN AN UNINTENDED MOTION OR UNCONTROLLED MOTION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418135 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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