BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22109929 · Received May 29, 2025

    Report

    Report Number
    2955842-2025-22745
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 15, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) 2 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND FOUND TO HAVE NO FUNCTIONAL ISSUES WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE MTM PASSED ALL RELEVANT TESTING, BUT THE ISSUE WAS CONFIRMED AS HAPPENING IN THE FIELD. THE EMBEDDED SERIALIZER IN MASTER BASE (ESMB) PRINTED CIRCUIT ASSEMBLY (PCA) AND MAIN WIRE HARNESS WERE FOUND TO BE CONSISTENT WITH THE ERROR. THE PROBABLE ROOT CAUSE IS DUE TO AN ISSUE WITH THE ESMB PCA AND THE MAIN WIRE HARNESS WITHIN THE MTM.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE AND REPLACED THE MASTER TOOL MANIPULATOR (MTM) 2. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNIT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE SURGEON LOST CONTROL OF MASTER TOOL MANIPULATOR (MTM) 2 USING THE LEFT-HAND CONTROL AT CONSOLE 1 AND WAS NOT ABLE TO REGAIN CONTROL OF THE MTM. THE CUSTOMER INFORMED THEY TRIED PRESSING THE ARM SWAP PEDAL, USING THE GIVE ALL/TAKE ALL FEATURE, AND CONFIRMED THE SURGEON'S HEAD WAS IN THE VIEWER WITH NO CHANGE. PRIOR TO CALLING THE SURGEON MOVED OVER TO CONSOLE 2 AND PROCEEDED WITH THE CASE. TSE RECOMMENDED PERFORMING A HARD REBOOT ON CONSOLE 1 AFTER THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529668 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-26 N/A 00886874110744

    Patients

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