BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18213380 · Received November 27, 2023

    Report

    Report Number
    2955842-2023-20529
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 1, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU) GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE IESU FOR EVALUATION. FAILURE ANALYSIS (FA) COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE IESU WAS ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE ERBE FAULTED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE ONSITE LOGS AND FOUND ERRORS M-18, M-11, AND C-38. THE STAFF CYCLED THE ERBE POWER, TRIED DIFFERENT INSTRUMENT CORDS, AND TRIED DIFFERENT INSTRUMENT, WITH NO RESOLUTION. THE TSE ASKED THE STAFF TO PULL THE ERBE POWER CORD, WITH THE ERBE POWERED UP. THE FAULTS RETURNED. THE TSE ASKED THE CUSTOMER TO USE A COVIDIEN GENERATOR IF POSSIBLE AND INFORMED THE SURGEON THEY COULD USE AND PLUG IN THE VESSEL SEALER EXTEND (VSE) INSTRUMENT INTO THE E-100 GENERATOR. THE SURGEON CONTINUED WITH THE CASE ROBOTICALLY. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE SITE AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE SYSTEM APPEARED NORMAL WHEN POWERED ON. THERE WERE NO ERRORS REPORTED ON STARTUP. THERE WERE ERBE ERRORS DURING THE FIRST CASE OF THE DAY, BUT IT WAS RESOLVED BY CHANGING THE MONOPOLAR CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523553 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