BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18688464 · Received February 12, 2024

    Report

    Report Number
    2955842-2024-11295
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 16, 2024
    Report Date
    January 16, 2024
    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
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED DUE TO VIDEO TEST. THE LEFT EYE TURNED YELLOW AND VERTICAL LINES MOVED UP/DOWN. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO RESOLVE THE ISSUE. ISI HAS RECEIVED THE PMSC, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOWUP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE IMAGE IN THE CONSOLE WAS YELLOW. THE CUSTOMER TRIED A SECOND SCOPE PRIOR TO CALLING WITHOUT RESOLVING. THE SYSTEM WAS HARD POWER CYCLED, AND THE ISSUE REMAINED. THE IMAGE IN THE RIGHT EYE WAS NORMAL. THE LEFT EYE IMAGE WAS STILL YELLOW. CONSOLE #2 WAS DISPLAYING THE IMAGE NORMALLY. THE SURGEON MOVED TO CONSOLE #2 AND RESUMED THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398003 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A

    Patients

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