BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23161991 · Received September 27, 2025

    Report

    Report Number
    2955842-2025-39805
    Event Type
    Malfunction
    Date Received
    September 27, 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 INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. SITE REPORTED THAT THE PREVIOUSLY REPORTED ISSUE HAS RECURRED. DURING THE PROCEDURE, THE SYSTEM EXPERIENCED RECOVERABLE FAULTS THAT ESCALATED TO NON-RECOVERABLE ERRORS. THE SYSTEM WAS RESTARTED, AND ALL FIBER CONNECTIONS WERE CHECKED. LOG REVIEW INDICATED AN ERROR RELATED TO THE PERSONALITY MODULE AUDIO / VIDEO (PMAV), AND A 307-ERROR REPORTED SUGGESTED A POTENTIAL PMAV ISSUE. PART HISTORY COULD NOT BE VERIFIED DUE TO MISSING PMAV SERIAL NUMBER. ALL PMAV CONNECTIONS WERE CONFIRMED SECURE, AND THE SURGEON PLANNED TO CONTINUE WITH SUBSEQUENT CASES. FSE VISITED THE SITE AND OBSERVED THE ERRORS. FSE REPLACED THE PMAV. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. 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 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 HYSTERECTOMY 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
    1663715 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-10 N/A

    Patients

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