BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15332332 · Received August 31, 2022

    Report

    Report Number
    2955842-2022-13785
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 3, 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
    IT
    Reporter Occupation
    003

    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. FSE WAS ABLE TO REPRODUCE THE ERROR E-31 ON THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) AND REPLACED THE IESU. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE VIO IESU 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 INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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 DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT ENGINEER (TSE) AND ISI FSE. ERROR E-31 AND M-02 COULD NOT BE FOUND IN THE LOGS, HOWEVER, MULTIPLE IESU ERRORS WERE FOUND IN THE LOG THAT MAY HAVE BEEN RELATED TO THE COMPLAINT. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM SK0421 WAS USED ON (B)(6) 2022 FOR A RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER DISCONTINUED USE OF THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) AND USED A THIRD PARTY GENERATOR (FORCE TRIAD) AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS. 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. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT REPLICATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE SYSTEM REFLECTED AN ERROR M-02 POINTING TO THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED TO THE CUSTOMER TO REBOOT THE IESU TO CLEAR THE ERROR AND TO CHANGE MONOPOLAR AND BIPOLAR CABLE AND TO TRY WITH ANOTHER PORT; BUT, THE ISSUE PERSISTS. THE CUSTOMER ELECTED TO USE A THIRD PARTY GENERATOR. THERE WAS NO REPORT OF PATIENT INJURY. ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT HARM, INJURY NOR DELAY. NO FRAGMENT FALL INTO PATIENT ANATOMY.

    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
    2595833 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.