BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23130048 · Received September 24, 2025

    Report

    Report Number
    2955842-2025-39142
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 4, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 EVENT. THE FSE VISITED THE SITE AND OBSERVED THE ERRORS. FSE REPLACED THE PERSONALITY MODULE AUDIO VIDEO (PMAV). 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 PMAV WAS ANALYZED AND FOUND THAT THE ISSUE WAS CONFIRMED BUT NOT REPLICATED BY THE FAILURE ANALYSIS. VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE REPORTED FAILURE. SYSTEM LOGS REPORTED ERROR 307 AND 23 NODE PMAV INDICATING A HARDWARE FAULT IN WHEEL COMMUNICATION, CONFIRMING A FIELD OCCURRENCE. THE PMAV WAS TESTED ON A GOLDEN PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM, FUNCTIONING CORRECTLY WITH NO ERRORS, GOOD IMAGE QUALITY, AND PASSING ALL I/O TESTS. AFTER 30 POWER CYCLES AND EXTENDED OPERATION, THE UNIT PERFORMED NORMALLY WITHOUT ANY ISSUES. THE PROBABLE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED AS THE FAILURE ANALYSIS DID NOT REPLICATE THE CUSTOMER REPORTED ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE PMAV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT REPEATED ERRORS 23 AND 307 OCCURRED. THE CUSTOMER RESTARTED THE SYSTEM AND CONFIRMED THAT ALL CONNECTIONS TO THE PERSONALITY MODULE AUDIO / VIDEO (PMAV) WERE TIGHT AND PROPERLY SEATED. THE TSE CONFIRMED ERROR 23 IN THE LOGS POINTING TO THE PMAV. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542123 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-10 N/A

    Patients

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