BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15601514 · Received October 13, 2022

    Report

    Report Number
    2955842-2022-14556
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 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
    MI, 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 ISI FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO MONOPOLAR ENERGY NOT FUNCTIONING FROM EITHER PORT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT REPRODUCE THE CUSTOMER REPORTED COMPLAINT OF "MONOPOLAR ENERGY WAS NOTE DETECTED". THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE UNIT WILL BE RESTOCKED FOR FUTURE USE. A LOG REVIEW CONFIRMED THE BENIGN HYSTERECTOMY PROCEDURE ON (B)(6)2022 ON SYSTEM SK2547. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, NO MONOPOLAR ENERGY WAS NOTED. THE ELECTROSURGICAL GENERATOR UNIT (ESU) WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A THIRD-PARTY 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

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, NO MONOPOLAR ENERGY WAS NOTED. THE NURSE CALLED IN TO REPORT THE ISSUE AND STATED THAT THE MONOPOLAR CURVED SCISSORS WERE CHANGED OUT, THE ENERGY ACTIVATION CABLE WAS EXCHANGED, AND THE ERBE WAS POWER CYCLED PRIOR TO CALLING IN. THE MCS WAS STILL NOT BEING RECOGNIZED ON THE ERBE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) HAD THE CUSTOMER TRY BOTH PORTS ON THE ERBE AND THE ISSUE PERSISTED. THE CALLER DIDN'T HAVE A 3RD GREEN INSTRUMENT ACTIVATION CABLE TO TRY. THE CUSTOMER SWAPPED THE MCS FROM ARM # 4 TO ARM # 2 AND THE ISSUE REMAINED. THEN, THE CALLER WAS IN THE PROCESS OF LOCATING A FORCE TRIAD GENERATOR AND ENERGY ACTIVATION CABLE WHEN THE CALL WAS DROPPED. THE TSE CALLED THE CUSTOMER BACK AND CONFIRMED THE SURGEON WAS ABLE TO PROCEED WITH THE PROCEDURE USING A THIRD-PARTY ENERGY SOURCE. THE FIELD ENGINEER HAS HIS CONTACT INFORMATION. THE SITE WAS COMPLETING THE PROCEDURE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889183 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

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