BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14824293 · Received June 26, 2022

    Report

    Report Number
    2955842-2022-12463
    Event Type
    Malfunction
    Date Received
    June 26, 2022
    Date of Event
    May 27, 2022
    Report Date
    May 27, 2022
    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
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 PERFORMED TROUBLESHOOTING AND INSTALLED NEW INTERNAL FIBER OPTIC CABLES AND ADAPTERS AND A NEW PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO CORRECT THE VISION PROBLEM. THE SYSTEM WAS THEN POWER OF AND OFF 30 TIMES TO ENSURE THE PROBLEM WAS CORRECTED. THE SYSTEM WAS ALSO TEST DRIVEN TO ENSURE INTUITIVE CONTROL AND MOTION. THE SYSTEM WAS READY FOR USE. THE PMSC IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT IT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE ITEM HAS BEEN RECEIVED AND FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. LOGS WERE REVIEWED AND IT WAS CONFIRMED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). 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 PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. HAS RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED ISSUE. THE PMSC WAS TESTED ON AN IN-HOUSE SYSTEM, AND THERE WAS NO VIDEO ON THE LEFT EYE. THERE WAS DAMAGE ON ALL 4 DIGITAL VIDEO INTERFACE (DVI) PORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, VISION ISSUES WERE ENCOUNTERED WITH THE LEFT EYE SHOWING BLACK ON THE SURGEON SIDE CONSOLE (SSC). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR TO REQUEST ADDITIONAL INFORMATION. IT WAS NOTED THAT THE CUSTOMER DID A FULL SYSTEM FUNCTIONALITY CHECK PRIOR TO THE PROCEDURE, BUT DID NOT CHECK THE CONSOLE VIEW. THE SURGEON WAS MADE AWARE OF THE FAULT AND WAS ABLE TO COMPLETE THE SIGMOID COLECTOMY PROCEDURE USING ONE EYE.

    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
    608953 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

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