BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19767233 · Received July 17, 2024

    Report

    Report Number
    2955842-2024-17107
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS WITH CUSTOMER SETUP. THE CUSTOMER CHECKED THE SETTINGS ON THE SURGEON CONSOLE AND ADJUSTED THE MANIPULATOR ASSOCIATION. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT WHEN THE DOCTOR WOULD PUSH THE BIPOLAR PEDAL THE MONOPOLAR ENERGY WOULD ACTIVATE, AND WHEN THE MONOPOLAR PEDAL WAS PUSHED THE BIPOLAR ENERGY WOULD ACTIVATE. THE DOCTOR HAD THE RESIDENT TRY THE PEDALS ON THE OTHER SURGEON SDE CONSOLE (SSC) AND THOSE ACTIVATED NORMAL SO THE DOCTOR SWAPPED CONSOLES WITH THE RESIDENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362546 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-15 N/A 00886874110744

    Patients

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