BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23023320 · Received September 11, 2025

    Report

    Report Number
    2955842-2025-37619
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 31, 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
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS ANALYZED AND FOUND SYSTEM LOG REVIEW CONFIRMED ERROR 23118 OCCURRED IN THE FIELD. VISUAL INSPECTION FOUND NO RELATED ISSUES. WHEN TESTED ON A GOLDEN SYSTEM, THE USM TRIGGERED ERROR 23118 ON POWER-UP. ON A PATIENT SIDE CART FIXTURE TEST PLATFORM, THE CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHAR TEST FAILED ON THE PITCH CVA. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IN THIS CASE IS ATTRIBUTED TO THE PITCH CHIPENCODER VIRTUAL ABSOLUTE (CVA) PRINTED CIRCUIT ASSEMBLY (PCA) OF THE USM. THIS ISSUE WAS RESOLVED BY REPLACING THE USM 4. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TECHNICAL SERVICE ENGINEER (TSE) WAS CONTACTED BY THE CUSTOMER REGARDING RECOVERABLE FAULTS OCCURRING ON THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM4). TSE REVIEWED THE SYSTEM LOGS AND VERIFIED ERROR 23118 OCCURRING ON THE USM4. PRIOR TO TSE BEING CONTACTED, THE CUSTOMER HAD PERFORMED A POWER CYCLE AND THE REPORTED EVENT PERSISTED. TSE WALKED THE CUSTOMER THROUGH A HARD POWER CYCLE AND EMERGENCY POWER OFF OF THE PATIENT SIDE CART, BUT THE SYSTEM ERROR CAME BACK DURING THE POWER UP. TSE SHARED WITH THE CUSTOMER THAT HE DA VINCI SYSTEM COULD BE UTILIZED AS A THREE ARM SYSTEM CONFIGURATION SETUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE REPORTED EVENT WAS IDENTIFIED AFTER PROCEDURE. THE SURGICAL PROCEDURE BEGAN AS A THREE ARM SYSTEM CONFIGURATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2709754 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