BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21845474 · Received April 15, 2025

    Report

    Report Number
    2955842-2025-14719
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    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 COMPLAINT. THE FSE SPOKE TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND CONFIRMED THAT THEY HAD NO FURTHER ISSUES. THE FSE WAS CLOSING THE CASE AS A PHONE FIX. NO SITE VISIT WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT THE RIGHT MASTER TOOL MANIPULATOR (MTM) DROPPED WHEN THE SURGEON LET GO OF THE GRIPS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THAT THIS MAY HAPPEN DUE TO PORT PLACEMENT AND GRAVITY, AND ADVISED ENSURING THE GRIPS WERE NOT RELEASED UNTIL THEY CAME OUT OF THE VIEWER. THE PROCEDURE WAS BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378784 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.