BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19945950 · Received August 8, 2024

    Report

    Report Number
    2955842-2024-17779
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 15, 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
    CA, 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 THE RIGHT MTM TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE MTM WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (DRIFTING) WAS REPRODUCED DURING SINE CYCLE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE MASTER TOOL MANIPULATOR (MTM) RIGHT WAS DRIFTING. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THE SURGEON WAS STILL ENGAGED WITH THE HIGH-RESOLUTION STEREO VIEWER (HRSV) WHEN LETTING GO OF THE MTM. THE CUSTOMER STATED THAT SURGEON WAS STILL ENGAGED WITH HRSV. THE TSE INFORMED CUSTOMER THAT IF SURGEON WAS ENGAGED WITH THE HRSV, THE SYSTEM THOUGHT THE SURGEON WAS STILL HOLDING THE MTM AND HE SHOULD NOT LET GO. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661323 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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