BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16329511 · Received February 8, 2023

    Report

    Report Number
    2955842-2023-10575
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 10, 2023
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MASTER TOOL MANIPULATOR (MTM) WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION COULD NOT REPRODUCE BUT CONFIRMED THE REPORTED ISSUE IN THE SYSTEM LOGS. VISUAL INSPECTION WAS PERFORMED. THE MTM WAS INSTALLED ONTO THE TEST SYSTEM AND POWERED UP. SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. TESTS PERFORMED VIA DATA TERMINAL EQUIPMENT (DTE) AND MATLAB SOFTWARE PASSED. THE FOLLOWING PARTS WILL BE REPLACED AS A PRECAUTION: EMBEDDED SERIALIZER IN MASTER BASE (ESMB) PRINTED CIRCUIT ASSEMBLY (PCA), EMBEDDED SERIALIZER IN MASTER PLATFORM (ESMP) PRINTED CIRCUIT ASSEMBLY (PCA), BLACK AND WHITE FLAT FLEX CABLES (FFC), SLIP RING ASSY, SLIP RING BOARD, MAIN WIRE HARNESS, MASTER JUNCTION BOARD (MJB) PCA, ROTARY JOINT PRIMARY (RJP) PCA, ROTARY JOINT SECONDARY (RJS) PCA, EMBEDDED SERIALIZER FOR MASTER YAW (ESMY) PCA, EMBEDDED SERIALIZER FOR MASTER HANDLE (ESMH) PCA, GIMBAL BLACK FFC, GIMBAL WHITE FFC, GIMBAL ORANGE FFC, GIMBAL BLUE FFC. NO ISSUE WAS FOUND ON THE MTM DURING EVALUATION. THE PROBABLE ROOT CAUSE OF THE SYSTEM EXPERIENCED A 25521-ERROR CODE 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 MTM FOUND NO ISSUES RELATED TO THE REPORTED COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM THAT THE SYSTEM EXPERIENCED A 25521 ERROR CODE, 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. FSE WAS ABLE TO CONFIRM THE ERROR CODE AND REPLICATE THE REPORTED EVENT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MTM EVALUATION IS IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE UNIT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED A 25521-ERROR CODE. THE CUSTOMER POWER CYCLED THE SYSTEM, AND THE ERROR CODE DID NOT PERSIST. A TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOG FILES AND NOTED ERROR 25521 ON MASTER TOOL MANIPULATOR LEFT 2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313471 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-26 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES