BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15222711 · Received August 13, 2022

    Report

    Report Number
    2955842-2022-13451
    Event Type
    Malfunction
    Date Received
    August 13, 2022
    Date of Event
    July 14, 2022
    Report Date
    July 14, 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
    MO
    Reporter Occupation
    NURSE
    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE WITH ERROR FAULTS AND THE MONOPOLAR ENERGY NOT FIRING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE IESU AND THE INVESTIGATION HAS BEEN COMPLETED. THE REPORTED ISSUES WERE CONFIRMED AND REPRODUCED. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE IESU WILL BE RETURNED TO THE MANUFACTURER FOR REPAIR. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE IESU WAS SHOWING ERROR C-34 WHEN THE SURGEON ATTEMPTED TO ACTIVATE MONOPOLAR ENERGY. THE IESU WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A THIRD-PARTY GENERATOR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS SHOWING ERROR C-34 WHEN THE SURGEON ATTEMPTED TO ACTIVATE MONOPOLAR ENERGY. THE OPERATING ROOM (OR) NURSE CONTACTED TECHNICAL SUPPORT AND REPORTED THE SURGEON COULD NOT GET MONOPOLAR ENERGY TO ACTIVATE. PRIOR TO CALLING TECHNICAL SUPPORT, THE CALLER SWITCHED OUT THE GREEN MONOPOLAR INSTRUMENT CABLE BUT THE ISSUE WAS NOT RESOLVED. THE CALLER ALSO ATTEMPTED TO SWAP OUT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITHOUT RESOLVING THE ISSUE. THE GROUNDING PAD WAS REGISTERED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER POWER OFF THE IESU AND DISCONNECT THE INSTRUMENT CABLES. THE IESU POWERED ON WITH A C-00 ERROR. NO OTHER ENERGY ACTIVATION DEVICES WERE PRESENT AT THE TIME OF THE CALL. THE CUSTOMER POWERED THE IESU OFF BY PULLING THE POWER CORD AND DISCONNECTING THE EXTERNAL FOOT PEDALS. THE IESU POWERED ON WITHOUT THE FAULT, HOWEVER, WHEN THE SURGEON ATTEMPTED TO ACTIVATE MONOPOLAR ENERGY, THE DEVICE FAULTED AGAIN. THE TSE ASSISTED THE CUSTOMER WITH CONNECTING A THIRD-PARTY GENERATOR. THE SURGEON WAS THEN ABLE TO ACTIVATE ENERGY USING THE THIRD-PARTY EQUIPMENT. THE SITE WAS CONTINUING THE PROCEDURE WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER SWAPPING TO THE BACKUP GENERATOR, THE PROCEDURE WAS COMPLETED WITHOUT ANY INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848806 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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