BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22091907 · Received May 27, 2025

    Report

    Report Number
    2955842-2025-22220
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 20, 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
    TW
    Reporter Occupation
    003

    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 WENT ON-SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND THE REPORTED 23094 ERROR WAS NOT CONFIRMED OR REPLICATED. IN THE SYSTEM LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT WAS FOUND TO BE FAILING THE INSERTION FRICTION TESTS. ONCE TESTING WAS COMPLETED, ALL SEARCHLIGHT, CHIPENCODER VIRTUAL ABSOLUTE (CVA), AND HALL SENSOR ASSEMBLIES WERE INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS FOUND [ADD FA RESULTS FOR NO PRODUCT ISSUE NO FUNCTIONAL ISSUES. THE USM WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE CUSTOMER INDICATED THE SYSTEM HAD A REPEAT RECOVERABLE FAULT 23094. THE USER TURNED/THE SYSTEM OFF AND ON WITH NO CHANGE. EVENTUALLY, THE SURGEON DISABLED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND COMPLETED THE PROCEDURE SUCCESSFULLY USING THE SAME DAVINCI SYSTEM. AFTER CHECKING THE LOG, THE TECHNICAL SUPPORT ENGINEER (TSE) FOUND ARM 1'S AXIS 3 ENCODER LOST THE SIGNAL, WHICH CAUSED THIS ERROR. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728226 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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