BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067636 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15844
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    June 22, 2021
    Report Date
    June 22, 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
    AS
    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 REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR TO RESOLVE THE ISSUE. NO ERRORS WERE FOUND IN THE LOG FILES. THE FSE PERFORMED ELECTRICAL SAFETY TESTS AND VERIFIED THE SYSTEM AFTER THE REPAIR. THE SYSTEM WAS RE-TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS INVESTIGATION FOUND NO IMAGE ON THE MONITOR DUE TO THE MAIN BOARD WAS DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) HIGH-RESOLUTION STEREO VIEWER (HRSV) RIGHT EYE HAD NO VISION. THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE USING A SECOND SSC WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM IS ALWAYS CONFIGURED AS A DUAL CONSOLE CONFIGURATION. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS AND FUNCTIONALITY WAS CHECKED. THE CUSTOMER EXPERIENCED THE RIGHT EYE VISION LOSS MID PROCEDURE. THE CUSTOMER CONTACTED A FSE AT THE TIME OF THE REPORTED PROBLEM; HOWEVER, FULL TROUBLESHOOTING WAS NOT COMPLETED BECAUSE THE SURGEON PREFERRED TO SWITCH TO THE SECOND CONSOLE RATHER THAN CAUSING DELAYS. THE FSE COMPLETED TROUBLESHOOTING AFTER THE PROCEDURE AND FOUND THE SSC HRSV REQUIRED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745119 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-14 N/A 00886874110744

    Patients

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