BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20583088 · Received October 31, 2024

    Report

    Report Number
    2955842-2024-21361
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 9, 2024
    Report Date
    October 9, 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 UNIT (IESU) TO RESOLVE THE REPORTED ISSUE WITH ENERGY ACTIVATION ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE IESU ASSOCIATED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE IESU WAS ANALYZED AND FOUND TO HAVE ERROR C-33 ON START-UP. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THERE WAS REPEATED ERROR C-33/C-00 ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE STAFF HAD TRIED TO POWER CYCLE THE GENERATOR WITH NO CHANGE. THE REPORTER EXPLAINED THE ISSUE WAS ONGOING. THE SITE WAS COMPLETING THE PROCEDURE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897164 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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