BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15482106 · Received September 25, 2022

    Report

    Report Number
    2955842-2022-14230
    Event Type
    Malfunction
    Date Received
    September 25, 2022
    Date of Event
    August 26, 2022
    Report Date
    August 26, 2022
    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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE CONFIRMED THE REPORTED COMPLAINT. ERROR 86 APPEARED DUE TO UNSTABLE POWER SUPPLY TO THE VISION SIDE CART (VSC) MAIN CONTROL UNIT. THE FSE REPLACED THE REDUNDANT POWER TRAY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE REDUNDANT POWER TRAY, AND FAILURE ANALYSIS (FA) TESTING HAS BEEN COMPLETED. THE REPORTED FAILURE WAS ABLE TO BE REPLICATED/CONFIRMED. THE COMPONENT WAS INSTALLED ON A TEST SYSTEM WHICH FAILED DURING START UP WITH AN ERROR 86 WHICH INDICATED AN OUT OF RANGE VOLTAGE RANGE. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A COMPONENT FAILURE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE WAS CONDUCTED BY A ISI TECHNICAL SUPPORT ENGINEER (TSE) WHEN THE CUSTOMER CALLED IN FOR ASSISTANCE AND BY THE FSE WHEN INSPECTING THE SYSTEM ONSITE. INVESTIGATION REVEALED ERROR 86 (POWER DISTRIBUTION BOARD ANALOG TO DIGITAL CONVERTER (ADC) FAULT - THE MASTER SUPERVISORY CONTROLLER (MSC) SAW AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12V) THAT MAY HAVE BEEN RELATED TO THE SYSTEM COMPLAINT. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM (B)(4) WAS USED ON (B)(6) 2022 FOR A SACROCOLPOPEXY PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE REDUNDANT POWER TRAY WAS REPLACED AFTER THE COMPLETION OF A SURGICAL PROCEDURE DUE TO REPEATED ERROR 86. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G3, G6, AND H2. EVALUATION INFORMATION CAN BE FOUND IN H6 AND H10. ON 09/23/2022, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE REDUNDANT POWER TRAY WAS RETURNED AND TESTED. THE REPORTED FAILURE WAS ABLE TO BE REPLICATED/CONFIRMED. THE COMPONENT WAS INSTALLED ON A TEST SYSTEM WHICH FAILED DURING START UP WITH AN ERROR 86 WHICH INDICATED AN OUT-OF-RANGE VOLTAGE RANGE. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 86 OCCURRED AT THE BEGINNING OF THE SURGERY. THE ERROR WAS RESOLVED WITH A POWER CYCLE, BUT THE SAME ERROR REOCCURRED MULTIPLE TIMES. AFTER THAT, THE TSE HAD THE CUSTOMER PERFORM A HARD POWER CYCLE, WHICH CLEARED THE ERROR. THE CUSTOMER CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS CONTINUING WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM WITHOUT ANY ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304568 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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