BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067655 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15858
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    February 23, 2021
    Report Date
    February 23, 2021
    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
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE REPLACED THE FOOTREST ASSEMBLY TO RESOLVE THE CAMERA SWITCH ERROR 31061. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOOTREST ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPRODUCED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT COULD NOT CONTROL THE CAMERA FROM THE SURGEON SIDE CONSOLE. VISUAL INSPECTION FOUND THAT THE UNIT HAD A DIRTY BOTTOM COVER. THE UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED WITH ERROR 31061. THE CAMERA PEDAL WAS ALSO FOUND TO BE SQUEAKY WHEN IT WAS PRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER COULD NOT CONTROL THE CAMERA FROM THE SURGEON SIDE CONSOLE (SSC). INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED ERROR 31061. A HARD POWER CYCLE WAS PERFORMED ON THE SYSTEM WITH NO SUCCESS. THE CUSTOMER DECIDED TO SWAP OUT THE SSC. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SECOND SSC WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745869 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-12 N/A 00886874110744

    Patients

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