BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18253016 · Received December 1, 2023

    Report

    Report Number
    2955842-2023-20788
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 9, 2023
    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
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE FAILURE ANALYSIS. THE POWER TRAY ASSEMBLY WAS ANALYZED, AND THE REPORTED ERROR 86 COULD NOT BE REPRODUCED BUT WAS CONFIRMED VIA ERROR SYSTEM LOGS. THE POWER TRAY ASSEMBLY WAS TESTED ON THE IN-HOUSE SYSTEM. THE SYSTEM STARTED IN NORMAL MODE WITH NO ERROR TRIGGERED AT START UP. THERE WERE NO ISSUES AFTER TEN POWER CYCLES. HOWEVER, THE VOLTAGE VALUE WAS SLIGHTLY BELOW THE MINIMUM RANGE, POINTING TO A POWER DISTRIBUTION ISSUE.

    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. THE FSE REPLACED THE POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    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 PROSTATECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT 86 OCCURRED. PRIOR TO CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, THE CUSTOMER RESTARTED SYSTEM WITHOUT IMPROVEMENT. THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CUSTOMER TO CONNECT THE ETHERNET CABLE AND PERFORM A HARD POWER CYCLE OF THE SYSTEM. IT WAS STATED THAT ALL POWER CORDS WERE CONNECTED TO A DEDICATED AC PLUG WITHOUT STRIP. THE SYSTEM CAME UP WITH A NON-RECOVERABLE FAULT 86 AGAIN, BUT THE SYSTEM WAS CONNECTED TO THE LIVE SYSTEM LOGS. THE LOGS WERE SHOWING ERROR 86, POINTING TO THE INTUITIVE SURGICAL POWER DISTRIBUTION (IPD), IN THE CORE. THE CUSTOMER TRIED A SECOND HARD POWER CYCLE JUST IN CASE, WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON WITHOUT ERRORS. THE PROCEDURE HAD BEEN IN PROGRESS FOR 3 HOURS WHEN THE ISSUE OCCURRED. THE PROCEDURE COULD BE COMPLETED ROBOTICALLY WITH THE ORIGINAL CONFIGURATION, AS THE PROBLEM HAD ARISEN AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429185 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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