BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19988553 · Received August 14, 2024

    Report

    Report Number
    2955842-2024-18155
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 16, 2024
    Report Date
    July 16, 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
    FL, 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 MASTER TOOL MANIPULATOR (MTM). THE FSE RECALIBRATED THE NEW MTM AND 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 (FA). THE MTM WAS ANALYZED AND THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED DURING VISUAL INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITH LYMPHADENECTOMY) SURGICAL PROCEDURE, THE RIGHT MASTER TOOL MANIPULATOR (MTM) CLUTCH WAS NOT WORKING. THE SURGEON WAS USING ANOTHER SURGEON SIDE CONSOLE (SSC) TO COMPLETE THE PROCEDURE. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED LOGS BUT CURRENT SYSTEM SHOWED THAT IT WAS NOT IN SURGERY. THE PROCEDURE WAS CONTINUING WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895001 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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