BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16001418 · Received December 17, 2022

    Report

    Report Number
    2955842-2022-15996
    Event Type
    Malfunction
    Date Received
    December 17, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT OF GETTING REPEATED M-02 ERRORS WAS CONFIRMED. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) OF THE RETURNED UNIT CONFIRMED AND REPRODUCED M-02/C-00/C-A1 ERRORS. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THE VISUAL INSPECTION FOUND THE UNIT WAS RETURNED IN GOOD CONDITION. A PROCEDURE LOG REVIEW WAS CONDUCTED, WHICH RESULTED IN THE FOLLOWING FINDINGS: THE LOGS SHOW THE CUSTOMER PERFORMED A HEMICOLECTOMY - LEFT PROCEDURE ON 31-OCT-2022 BY THE LISTED CONSOLE SURGEON ON SYSTEM SK4570. A REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE POSSIBLE RELATED SYSTEM ERRORS: ERROR CODE: 25913; IESU ERROR C-82; AND IESU ERROR: M-02. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE FAILURE ANALYSIS CONFIRMED AND REPRODUCED M-02/C-00/C-A1 ERRORS. ALSO, COMPLAINT INVESTIGATION CONFIRMED THAT THE FIELD SERVICE ENGINEER (FSE) REPLACED THE IESU TO RESOLVE THE ISSUE. 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 THE 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 HEMICOLECTOMY LEFT SURGICAL PROCEDURE, THE INTUITIVE SURGICAL INC (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SITE WAS GETTING AN M-02 ERROR DURING THE PROCEDURE. THE CSR STATED THAT THE SITE POWER CYCLED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, AND THE ERROR MESSAGE WAS CLEARED. THE SITE WAS ABLE COMPLETE THE PROCEDURE AFTER REBOOTING THE GENERATOR. THE CSR REPORTED THAT AFTER POWER CYCLING THE GENERATOR AFTER THE PROCEDURE, THE ERROR MESSAGE RETURNED. THE TSE INSTRUCTED THE CSR TO PERFORM ONE-MINUTE GENERATOR REBOOT, AND THE ERROR MESSAGE CLEARED. THE TSE INFORMED CALLER THAT ERROR COULD RETURN AND RECOMMENDED THAT SITE BE INFORMED ON HOW TO SETUP A FORCE TRIAD GENERATOR AS A BACKUP IF NEEDED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DA VINCI COORDINATOR RESPONDED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE ISSUE WAS THAT THE GENERATOR WAS NOT SENSING THE GROUNDING PAD. TROUBLESHOOTING WAS DONE BY REBOOTING THE GENERATOR. AFTER REBOOTING THE GENERATOR WAS ABLE TO SENSE THE GROUND PAD. THE DA VINCI COORDINATOR THINKS THE PROCEDURE WAS COMPLETED USING THE SAME ERBE GENERATOR BUT WAS NOT ABLE TO BE CERTAIN. THERE MUST HAVE BEEN A PROCEDURE DELAY OF 15-30 MINUTES. THE SURGEON DID NOT WANT THE ISSUE TO HAPPEN AGAIN AND DO NOT PREFER REBOOTING THE SYSTEM IN MIDDLE OF PROCEDURE IN FUTURE CASES, SO THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CHECK THE SYSTEM. THE FSE REPLACED THE ERBE GENERATOR TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701104 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A

    Patients

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