BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20929144 · Received December 13, 2024

    Report

    Report Number
    2955842-2024-23229
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 19, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO REPRODUCE THE ISSUE BUT SAW THE ERROR IN THE SYSTEM LOGS. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE HRSV TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO REPRODUCE ISSUE. THE MONITOR WAS INSTALLED ON OUR PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM, AND IT STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. THE SYSTEM IDLED FOR 1 HOUR AND VISUALLY VERIFIED THAT THERE WERE NO ISSUES. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SURGEON SIDE CONSOLE (SSC) 1 RIGHT-EYE DISPLAY ISSUE OCCURRED. THE TSE CONFIRMED THAT AN ERROR 119 OCCURRED BUT DID NOT FIND ANY OTHER ERRORS RELATED TO THIS ISSUE. THE VISION SIDE CART FOR BOTH EYES AND SSC 2 FOR BOTH EYES DISPLAYED CORRECTLY. THE TSE ADVISED HIM TO PERFORM A HARD POWER CYCLE ON SSC 1. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THE SURGEON RESUMED ON THE REMAINING CONSOLE AND COMPLETED THE PROCEDURE WITH SINGLE SSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858548 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-14 N/A 00886874110744

    Patients

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