BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18261910 · Received December 4, 2023

    Report

    Report Number
    2955842-2023-20821
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 8, 2023
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 EVENT. THE FSE REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR DUE TO NO SIGNAL IN ONE OR BOTH EYES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HRSV MONITOR WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION WAS CONFIRMED. THE MONITOR WAS INSTALLED ON THE RIGHT SIDE OF THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. UPON POWER UP, THE SYSTEM WAS BOOTED UP WITH NO ISSUES, EXCEPT THE RIGHT EYE MONITOR WAS COMPLETELY DEAD. NO IMAGES WERE SHOWN ON THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE RIGHT EYE HAD LINES IN THE SURGEONS SIDE CONSOLE (SSC). THE CUSTOMER CONFIRMED NO ISSUES WITH THE OTHER SCREENS OR THE VISION SIDE CART (VSC) WHEN RIGHT EYE WAS SELECTED. THE CUSTOMER HAD ISSUES ON ALL 3 PROCEDURES AND THE ISSUE HAD GOTTEN WORSE. THE CUSTOMER HAD NOT RESTARTED THE SYSTEM. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER THROUGH A POWER CYCLE OF THE SSC USING THE SSC BREAKER. THE SYSTEM POWERED UP AND THE RIGHT EYE WAS MISSING. THE TSE THEN WALKED THE CUSTOMER THROUGH A SECOND POWER CYCLE AND THE RIGHT EYE WAS MISSING A SECOND TIME. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM DID POWER ON WITHOUT ISSUES AND THE SURGEON NOTED LINES THROUGH THE RIGHT EYE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SAME SYSTEM WITH BOTH EYES PRESENT HOWEVER THE LINES ON THE RIGHT EYE MADE IT CHALLENGING. THE ISSUE GOT WORSE THROUGHOUT THE PROCEDURE FOR THE DAY. THE SURGEON DID NOT WANT TO RESTART THE SYSTEM AS THE CUSTOMER WAS CONCERNED THAT IT WOULD BE COMPLETELY OFF. THE ISSUE MIGHT HAVE BEEN CAUSED AS THE CUSTOMER MOVED THE SYSTEM FROM ONE ROOM TO ANOTHER AND IN DOING SO THERE MIGHT HAVE BEEN DUST THAT GOT INTO THE BLUE FIBER CABLE. ALL THREE PROCEDURES WERE COMPLETED WITH THE SAME SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160639 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

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