BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16644668 · Received March 30, 2023

    Report

    Report Number
    2955842-2023-11640
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 4, 2023
    Report Date
    March 4, 2023
    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
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS ANALYZED, AND FAILURE ANALYSIS WAS NOT ABLE TO REPLICATE THE REPORTED ISSUE. NO FAILURES WERE FOUND. THE UNIT ENERGIZED, CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT REGARDING BIPOLAR ENERGY ISSUES WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE EXTERNAL FOOT PEDAL WAS NOT WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE CONFIRMED THAT THE CONNECTORS ON THE PACK FOR THE PEDALS WERE NOT WORKING. FSE REPLACED THE ERBE GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE GENEATOR BUT THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE ELECTROSURGICAL GENERATOR UNIT (ESU) WAS ABANDONED/REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP ESU. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE BIPOLAR ENERGY LEVEL WAS SET TO FOUR AND THE SURGEON WAS NOT GETTING PROPER ENERGY. THE CUSTOMER TRIED SWAPPING OUT THE INSTRUMENT'S ENERGY CORD, BUT THE ISSUE REMAINED. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND NOTED NO ERRORS. THE REPORTED ISSUE WAS OBSERVED AT THE END OF THE PROCEDURE WHEN THE ISSUE OCCURRED. THE CUSTOMER STATED THE GROUNDING PAD WAS GREEN BUT ENDED UP MOVING THE HANDHELD INSTRUMENT TO ANOTHER GENERATOR TO GET IT TO WORK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON UNDOCKED ONE ARM AND USED A LAPAROSCOPIC INSTRUMENT TO DO THE CAUTERY THAT WAS NEEDED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WERE NO ADDITIONAL PORTS ADDED. THE SURGEON USED THE EXISTING PORTS TO COMPLETE THE PROCEDURE. THE PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566402 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