BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20282131 · Received September 23, 2024

    Report

    Report Number
    2955842-2024-19383
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 CORE REDUNDANT POWER TRAY ASSEMBLY AND THE CORE FAN ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE CORE REDUNDANT POWER TRAY ASSEMBLY INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. THE UNIT WAS INSTALLED INTO A TEST SYSTEM AND THE REPORTED FAILURE WAS REPLICATED. THE TEST SYSTEM STARTED UP WITH ERROR 1102, INDICATING THE FAN NOT WORKING. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE CORE FAN ASSEMBLY IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, RECOVERABLE FAULT 1102 OCCURRED. THE INTUITIVE SURGICAL, INC. (ISI) TECH SUPPORT ENGINEER (TSE) OBSERVED THE ERROR 1102 IN THE SYSTEM LOGS AGAINST THE VISION SIDE CART (VSC) FAN TRAY ASSEMBLY. CUSTOMER REPORTED THE SAME MESSAGE DISPLAYED ON THE SCREEN. PRIOR TO CONTACTING THE TSE, THE SURGEON REMOVED THE VSC CORE BEZEL AND FILTER. THE TSE WALKED THE CUSTOMER THROUGH REINSTALLATION OF THE BEZEL. THE TSE ADVISED THAT THE TEMPERATURE MESSAGE WOULD NOT DISAPPEAR UNTIL THERE WAS A POWER CYCLE OF THE SYSTEM, EVEN IF THE ERROR CONDITION HAD CLEARED. THE CUSTOMER OPTED TO POWER CYCLE BETWEEN CASES. THE CUSTOMER CALLED BACK AT A LATER TIME AND ASKED IF THEY COULD USE THE SYSTEM. THE TSE ADVISED THAT IF THE SYSTEM BECAME TOO HOT IT WOULD SHUT DOWN AND WOULD HAVE TO COOL DOWN BEFORE BEING POWERED BACK UP. THE CUSTOMER STATED THAT THEY WOULD SPEAK WITH THE SURGEON REGARDING THE NEXT STEPS. THE PROCEDURE COMPLETED AS PLANNED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: A RECOVERABLE FAULT DID OCCUR WHEN THE SYSTEM WAS INITIALLY POWERED ON. THE CUSTOMER WAS ABLE TO RECOVER THE FAULT VIA THE VISION SIDE CART, AS THE SURGEON SIDE CONSOLE HAD NOT BEEN TURNED ON YET. THE OVERHEATING MESSAGE DID NOT OCCUR UNTIL DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671956 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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