BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19336035 · Received May 16, 2024

    Report

    Report Number
    2955842-2024-14515
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 18, 2024
    Report Date
    April 18, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CALLED TO FOLLOW UP WITH THE ROBOTICS COORDINATOR, WHO STATED THE CLINICAL STAFF SUSPECTED THERE MAY HAVE BEEN AN ISSUE WITH THE ERBE GENERATOR. THEREFORE, AFTER THE PROCEDURE, THE ROBOTICS COORDINATOR UNINSTALLED IT FROM DA VINCI SYSTEM #SK4651 AND REPLACED IT WITH ANOTHER SYSTEM. THE ERBE GENERATOR WAS THEN SENT TO THE BIOMEDICAL ENGINEERING DEPARTMENT WHO STATED A THIRD PARTY INVESTIGATION WAS NEEDED AND THE FSE WAS DENIED ACCESS TO THE GENERATOR. ONCE ALLOWED TO INSPECT THE VISION SIDE CART (VSC), IT WAS FOUND TO HAVE HAD THE ERBE CHASSIS CAGE REMOVED AS WELL; THEREFORE, THE FSE COULD NOT REINSTALL THE NEW ERBE. THE NEXT DAY THE FSE WAS ABLE TO RETRIEVE THE ERBE CHASSIS CAGE FROM SECURITY AT THE SITE. UPON FURTHER INSPECTION OF THE VISION SIDE CART (VSC), IT WAS NOTED THE FOLLOWING ITEMS HAD BEEN DRILLED AND MOUNTED INTO THE VSC: POWER STRIP, AIR SEAL MOUNT, AND GAS TANK/LINES. THE FSE INSTALLED THE NEW ERBE, TEST DROVE THE SYSTEM, AND VERIFIED IT AS READY FOR USE. ADDITIONALLY, THE FSE PERFORMED ELECTRICAL SAFETY CHECKS ON FOR THE MAIN CART COMPONENTS. ISI HAS NOT RECEIVED THE GENERATOR FOR FAILURE ANALYSIS EVALUATION. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THERE WERE ISSUES WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND THE PATIENT NEUTRAL PAD. THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THE PATIENT NEUTRAL PAD WAS NOT SHOWING THAT IT WAS ON AND AFTER SEVERAL TRIES THE CUSTOMER WAS ABLE TO GET THE PATIENT NEUTRAL PAD TO WORK. UPON FINISHING THE PROCEDURE, A SMALL DIME SIZE MARK THAT INITIALLY LOOKED A LITTLE BIT LIKE A TEAR NEAR THE PATIENT NEUTRAL PAD SITE ON THE RIGHT THIGH WAS NOTED. ONCE IN THE RECOVERY ROOM THE PATIENT COMPLAINED OF PAIN AND WHAT FIRST APPEARED AS A TEAR, LATER APPEARED TO BE A BURN. DURING FOLLOW UP WITH THE INITIAL REPORTER, IT WAS LEARNED THAT THE PATIENT NEUTRAL PAD WAS REPLACED AFTER TRYING TO COMPRESS/LEAN ON THE ORIGINAL PATIENT NEUTRAL PAD IN ORDER TO TRY AND GET A CONNECTION. ONCE THE PAD WAS REPLACED, THE MONOPOLAR ENERGY WORKED. WHEN THE INJURY WAS INITIALLY NOTED AT THE END OF THE PROCEDURE, IT WAS NOT RED OR SUNKEN, IT WAS DRY AND FLAT. ONCE THE PATIENT WOKE UP IN PAIN, WOUND CARE WAS CONSULTED AND AT THIS POINT, THE INJURY WAS WELTED, INDENTED, AND THE THERMAL REACTION WAS VISIBLE. HOWEVER, THE SIZE HAD NOT CHANGED. IT IS UNKNOWN HOW OR WHY THIS BURN OCCURRED. IT IS ALSO UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATION. THE REPORTER DENIED WETNESS TO THE SITE, DEFECTS ON THE PAD THAT WAS REPLACED, OR ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454745 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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