BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19659439 · Received July 2, 2024

    Report

    Report Number
    2955842-2024-16539
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 10, 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
    LA, US
    Reporter Occupation
    NURSE
    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 ERBE TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ERBE INVOLVED WITH THE COMPLAINT AND COMPLETED THE EVALUATION. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, C-34 ACTIVATION ERRORS OCCURRED WHEN MONOPOLAR ENERGY WAS USED. PRIOR TO CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER TRIED POWER CYCLING THE ERBE GENERATOR, REPLACING THE INSTRUMENT ENERGY CORD AND INSTRUMENT WITH NO CHANGE. THE TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED PERFORMING A HARD POWER CYCLE THE VISION SIDE CART (VSC) WHEN POSSIBLE AND LOCATING A BACKUP GENERATOR OR USING A DIFFERENT VSC. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED NO FURTHER DETAILS RELATED TO THE REPORTED EVENT ARE KNOWN OR AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603070 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