BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20658891 · Received November 11, 2024

    Report

    Report Number
    2955842-2024-21763
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 16, 2024
    Report Date
    October 16, 2024
    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
    NC, 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 EVENT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ISOLATED LYSIS OF ADHESIONS SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) HAD ERROR CODES M-10, M-11, M-B1, AND M-BC WHICH WERE ALL PRESENTED IN THE LOGS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED TO REMOVE THE EXTERNAL FOOT PEDALS AND WAS WATCHING THE SURGEON SIDE CONSOLE (SSC) FOOT PEDALS IN THE LOGS. WITH NOTHING CONNECTED TO THE IESU, IT WAS RESTARTED AND ERRORED ON START-UP, AND AN ENERGY ACTIVATION TONE COULD BE HEARD EVEN THOUGH NOTHING WAS CONNECTED. THE ENERGY PEDALS ON THE SSC WERE ALL SHOWING IN THE UP POSITION. THE SITE WOULD USE A THIRD-PARTY DEVICE TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514192 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES