BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17046229 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15560
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) (951300-03) AND DISCOVERED IT WAS DIRECTLY PLUGGED INTO THE VISION SIDE CART (VSC) POWER STRIP. IT WAS NOTED THE ISI WARNING COVER WAS REMOVED AND ALLOWED ACCESS TO POWER STRIP. THIS WAS BROUGHT TO THE CUSTOMERS ATTENTION AND WERE INSTRUCTED THIS WAS NOT WHERE THE IESU SHOULD BE POWERED FROM. AFTER, THE FSE PROCEEDED TO REPLACE THE IESU AND PROVIDED THE ISI POWER CORD TO PROPERLY POWER THE REPLACEMENT. DURING THE TEST DRIVE, THE FSE WAS ABLE TO TEST TWO OF FOUR OF THE IESU PORTS BEFORE HAVING TO LEAVE THE ROOM DUE TO A SECOND CASE. IT WAS NOTED THE IESU WAS GENERATING BURNS ON BOTH MONOPOLAR AND BIPOLAR TEST INSTRUMENTS. THE FSE FOLLOWED UP WITH THE ROBOTIC COORDINATOR (ROCO) AFTER THE COMPLETION OF THE CASE AND WAS INFORMED THE IESU REPLACEMENT WORKED WITH NO ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT REPLICATE THE REPORTED COMPLAINT. THE IESU UNIT ENERGIZED, CAUTERIZED, AND ALL PORTS RECOGNIZED THE INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THERE WAS NO ENERGY COMING FROM THE ERBE. THE CUSTOMER INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THEY HAD TRIED DIFFERENT INSTRUMENT ENERGY CORDS, REPLACED THE GROUNDING PAD, AND EVEN POWER CYCLED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU), BUT NEITHER MONOPOLAR OR BIPOLAR WAS WORKING. AS THE TSE WAS WAITING FOR THE LOG TO COME UP, THE CUSTOMER STATED THE SURGEON HAD DECIDED TO OPEN AND HAD TO GO. THE CUSTOMER ENDED THE CALL BEFORE ANY TROUBLESHOOTING COULD BE PERFORMED. AFTER, THE TSE VIEWED THE SYSTEM LOGS AND FOUND ERROR M-35 FOR A NON-MOUNTED DAVINCI INSTRUMENT. THE CUSTOMER CALLED BACK TO SEE IF THERE WERE ANY ADDITIONAL TROUBLESHOOTING STEPS TO COMPLETE. SINCE THE LOGS INDICATED AN EXTERNAL ACTIVATION HAD HALTED THE SYSTEM, THE TSE HAD THE CUSTOMER REMOVE BOTH FOOT PEDAL CONNECTIONS FROM THE BACK OF THE ERBE. THEN ASKED THE CUSTOMER TO RE-SEAT THE COMM CABLE AND POWER CORD AS WELL. IT WAS NOTED THE ERBE WAS POWERED UP NORMALLY WITH NO MESSAGES OR WARNINGS. THE CUSTOMER INFORMED THEY WOULD TRY TO USE THE SYSTEM FOR THE NEXT PROCEDURE. THERE WAS NO REPORTED INJURY OR HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR (ROCO) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROCO INFORMED THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO PORT PLACEMENT ISSUE WAS OBSERVED. IT WAS CONFIRMED THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE ERBE GENERATOR NOT WORKING AND THE SURGEON DID NOT WANT TO WAIT. THE ROCO STATED THE SURGEON FIRST CONVERTED TO LAP AND THEN CONVERTED TO OPEN. THE SURGEON BELIEVED THE REPORTED ISSUE OCCURRED BECAUSE THERE WAS NO ENERGY. IT WAS NOTED THE CUSTOMER DID NOT HAVE A BACKUP ENERGY SOURCE. THE ROCO DID NOT KNOW HOW LONG THE PROCEDURE HAD BEEN IN PROGRESS PRIOR TO THE REPORTED ISSUE. NO IMAGE/VIDEO WAS AVAILABLE FOR REVIEW. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED OPEN WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30232 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-10 N/A

    Patients

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