BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15173523 · Received August 5, 2022

    Report

    Report Number
    2955842-2022-13339
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 8, 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
    GM
    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. TO CORRECT THE ISSUE, FSE REPLACED THE ELECTRO SURGICAL UNIT (IESU) VIO. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE REPLACED UNIT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO AN EXTERNAL INTEGRATED ELECTRO SURGICAL UNIT (IESU) AFTER THE START OF THE PROCEDURE DUE TO VIO GENERATOR DISPLAYED A NON-RECOVERABLE ERROR. A THIRD PARTY GENERATOR WAS USED TO COMPLETE THE SURGICAL TASK. 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

    ADDITIONAL INFORMATION FOUND IN: D9, H2, H3, H10 INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. UPON POWERING ON THE IESU, ERROR C-54 WAS OBSERVED. THE IESU WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER FOR REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) VIO DISPLAYED SEVERAL ERRORS. THE CUSTOMER INDICATED AN EXTERNAL IESU WAS USED TO PROCEED WITH THE CASE. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED SEVERAL C-34 AND C-54 ERRORS. 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 THE DATE OF THIS REPORT.

    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
    2518625 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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