BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19372057 · Received May 22, 2024

    Report

    Report Number
    2955842-2024-14752
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 26, 2024
    Report Date
    April 26, 2024
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED. THE FSE PROVIDED ERROR LOGS FOR THIS USM, AND WE WERE ABLE TO CONFIRM 31226 ERRORS, INDICATING A COMMUNICATION FAULT WITH THE CLOCKSPRING FIBER. ON OUR SYSTEM, THE UNIT TRIGGERED A 31226 ERROR, INDICATING A COMMUNICATION FAULT WITH THE CLOCKSPRING FIBER. THE UNIT WAS ABLE TO FINISH THE REST OF SYSTEM AND PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) TESTING WITHOUT TRIGGERING ANY OTHER RELEVANT FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD A RECOVERABLE FAULT, AND THE ARMS WERE NOT WORKING. THE SITE EXPLAINED THAT THERE WAS A TIP UP FENESTRATED GRASPER INSTALLED ON ARM 1, AS WELL AS A CADIERE FORCEPS INSTRUMENT INSTALLED ON ARM 2 THAT ARE BOTH STUCK GRASPING TISSUE. AFTER CONFIRMING, THE SURGEON HAD VISUALIZATION OF THE INSTRUMENT TIPS. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMER ACTIVATE THE E-STOP BUTTON AND UTILIZE THE INSTRUMENT RELEASE KIT TO OPEN THE INSTRUMENT JAWS, RELEASING THE TISSUE. CUSTOMER CONFIRMED THEY WERE ABLE TO SUCCESSFULLY REMOVE THE INSTRUMENTS WITH NO PATIENT INJURY. THE CUSTOMER POWER CYCLED THE SYSTEM AND THE SYSTEM POWERED BACK ON SUCCESSFULLY WITH NO ERRORS. ALSO, TSE ADVISED CUSTOMER THAT SYSTEM LOGS REFLECT ARM 3 ERRORS RESULTING IN A RECOVERABLE FAULT. SYSTEM LOGS THEN SHOW ARM 3 WAS DISABLED BY THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608764 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES