BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17074122 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15972
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    September 3, 2020
    Report Date
    September 3, 2020
    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
    NY, 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 FSE FOUND THAT THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) GENERATOR STARTED UP BUT IT HAD A DIFFERENT SCREEN UPON START UP, SO THE IESUWAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) ALSO RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED DURING INVESTIGATION. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND TEST WAS PERFORMED USING THE SAME INSTRUMENTS, BUT THE FAILURE COULD NOT BE REPLICATED. THE UNIT ENERGIZED AS WELL AS CAUTERIZED AND ALL PORTS RECOGNIZED THE INSTRUMENTS. NO ISSUES OR ABNORMALITIES OCCURRED. THE COMPLAINT OF NO ENERGY OUTPUT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE ELECTRO SURGICAL UNIT (IESU) GENERATOR POWERED OFF MID-PROCEDURE. AFTER THE ISSUE HAD OCCURRED EARLIER, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE ISSUE. THE CUSTOMER STATED THAT THEY CONFIRMED ALL THE CONNECTIONS ON THE BACK OF THE IESU AND THEY WERE SECURE, BUT THE IESU REMAINED OFF. THE CUSTOMER STATED THAT THEY HAD TO SWAP OUT THE VISION SIDE CART (VSC), FROM A DIFFERENT SYSTEM IN ORDER TO PROCEED WITH THE CASE ROBOTICALLY. THE CUSTOMER STATED THAT THE IESU GENERATOR FROM THE OTHER SYSTEM WAS PLUGGED INTO THE SAME OUTLET AS THE ORIGINAL IESU AND IT WAS WORKING. THE CUSTOMER ATTEMPTED TO POWER THE IESU ON AFTER THE PROCEDURE, BUT IT STILL WOULD NOT POWER ON. THE CUSTOMER SUSPECTED A POSSIBLE BLOWN FUSE ON THE IESU DEVICE. THE TSE ATTEMPTED TO REVIEW ERROR LOGS, BUT THE SYSTEM WAS NOT CONNECTED TO THE NETWORK SO LOGS WERE NOT VISIBLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE USE OF A DIFFERENT VSC AND IESU, WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020658 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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