BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14812323 · Received June 25, 2022

    Report

    Report Number
    2955842-2022-12400
    Event Type
    Malfunction
    Date Received
    June 25, 2022
    Date of Event
    May 26, 2022
    Report Date
    May 25, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 COMPLAINT. THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV-L) ON THE SURGEON SIDE CONSOLE (SSC) DISPLAYED BLACK SCREEN. THE FSE FOUND ERROR 121 IN THE ERROR LOGS AND REPLACED THE HRSV-L OF THE SSC 1 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPRODUCED THE REPORTED FAILURE. THE MONITOR WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM STARTED UP WITH NO IMAGE ON THE LEFT HRSV MONITORS AND THE SCREEN WAS COMPLETELY BLACK. THE ROOT CAUSE OF THE ISSUE WAS FOUND TO BE A COMPONENT FAILURE. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF THE ERROR FAULT DURING A PROCEDURE ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM (B)(4) MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI FSE'S INVESTIGATION. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO ANOTHER SURGEON SIDE CONSOLE (SSC) AFTER THE START OF THE PROCEDURE DUE TO A VISION ISSUE . WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE AFTER THE PATIENT WAS UNDER ANESTHESIA, THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV-L) ON THE SURGEON SIDE CONSOLE (SSC) DISPLAYED A BLACK SCREEN. THE CUSTOMER PERFORMED A POWER CYCLE OF THE SYSTEM TWICE, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM TO CONTINUE THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON POWERING ON THE SYSTEM, THE SYSTEM FUNCTIONALITY WAS CHECKED AND THERE WAS NO ERROR FOUND. AFTER PORTS PLACEMENT, THE CUSTOMER WAS UNABLE TO SEE THROUGH THE HRSV. THE CUSTOMER DID NOT CONTACT TECHNICAL SUPPORT FOR TROUBLESHOOTING AND ELECTED TO USE THE SSC 2 TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633647 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-15 N/A 00886874110683

    Patients

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