BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21243613 · Received January 27, 2025

    Report

    Report Number
    2955842-2025-00858
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 31, 2024
    Report Date
    December 31, 2024
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON BACKPLANE WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN THE GOLDEN SYSTEM WAS SET TO RUN THE VIDEO TEST, PORTS/CONNECTORS CHECKED, PERFORMED 10 POWER CYCLES AND SAT IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR 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 OF THE SBP FOUND NO ISSUES. THE PRODUCT 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. THE GCC WAS INSTALLED ONTO A GOLDEN IS4000 SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE GCC. IT FAILED ERROR 42 AT START UP IS THE POTENTIAL ROOT CAUSE FOR THIS ISSUE.

    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. THE FSE WAS ABLE TO REPLICATE THE ERROR 42 ON THE SYSTEM. THE FSE REPLACED THE GENERIC CART CONTROLLER (GCC) COMPONENT, SURGEON BACK PLANE (SBP) AND THE PEDAL FOOTREST TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE GCC AND SBP FOR EVALUATIONS, BUT EVALUATIONS HAVE NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. ISI RECEIVED THE PEDAL FOOTREST INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED ERROR 42 WAS CONFIRMED IN THE LOG BUT NOT REPLICATED. VISUAL INSPECTION FOUND NO ISSUES WITH THE UNIT. THE PEDAL FOOTREST WAS INSTALLED ON A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE GOLDEN SYSTEM WAS SET TO RUN PEDALS TEST, TEN POWER CYCLES AND SITTING IDLE FOR ONE HOUR. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY RECEIVED ERROR 42 POINTING TO THE FOOT TRAY ON THE SURGEON SIDE CONSOLE (SSC). THERE WAS NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE TRIED TO TROUBLESHOOT BY RESTARTING THE SYSTEM MULTIPLE TIMES, AND NO CONNECTIONS WERE LOOSE FROM THE FOOT PEDAL UPON INSPECTION. THE SSCS WERE CHANGED MID-CASE, BUT UNFORTUNATELY THE SOFTWARE VERSIONS WERE DIFFERENT SO THEY COULD NOT PROCEED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. NO ADDITIONAL PORTS WERE PLACED. THE PATIENT TOLERATED THE CHANGE WELL. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606365 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-08 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES