BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21568815 · Received March 10, 2025

    Report

    Report Number
    2955842-2025-05815
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 11, 2025
    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
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE DISTAL SETUP JOINT (SUJ) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE DISTAL SUJ WAS ANALYZED AND INSTALLED DISTAL ONTO KNOWN GOOD SYSTEM WHERE 32100 WAS REPLICATED ON STARTUP. TESTED THE DISTAL SUJ ON PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE WRIST BRAKE FAILED TO UNLOCK DURING TESTING. ABA TESTED SETUP FRU LOWER (SFL) BOARD AND AXES CONTROLLER TORNADO (ACT) BOARD WITH CONTINUED FAILING RESULTS. TESTED WRIST BRAKE ON POWER SUPPLY WHERE BRAKE ENGAGED & DISENGAGED WITH NO ISSUES RECEIVING POWER. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO FAILURES IN THE WRIST BRAKE AND CABLE ASSEMBLIES.

    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 REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, REPEATED RECOVERABLE ERRORS OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) #2. SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). TSE CONFIRMED ERROR 32100 POINTING TO THE DISTAL SET UP JOINT (SUJ). SITE POWER CYCLED THE SYSTEM A FEW TIMES, BUT THE ISSUE WAS NOT RESOLVED. TSE ADVISED SITE TO DISABLE USM #2; HOWEVER, SITE NEEDED ALL FOUR USM ARMS FOR THE PROCEDURE. AFTER, SITE CALLED BACK TO REPORT THAT AFTER DISABLING USM #2, NONE OF GUIDED SETUP FUNCTIONS WERE WORKING: THE SYSTEM WOULD NOT PROMPT THE USER TO DEPLOY FOR DRAPING, DOCKING OR TARGETING, AND THE TABLE MOTION COULD NOT BE TURNED ON. THE PROCEDURE WAS DELAYED FOR ONE HOUR DUE TO THE ISSUE. SITE WAS ABLE TO MANUALLY POSITION THE SYSTEM AND INSTALL INSTRUMENTS TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337171 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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