BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3405437 · Received October 10, 2013

    Report

    Report Number
    2955842-2013-04303
    Event Type
    Other
    Date Received
    October 10, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSMC COMPONENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPLICATE THE REPORTED 48200 ERROR. THE ERROR CODE POINTED TO THE SURGEON CONSOLE LEAF (SCL) AS NOT BEING DETECTED. VISUAL INSPECTION REVEALED NO ISSUES WITH THE RETURNED COMPONENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DA VINCI SI PROSTATECTOMY PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE DUE TO THE RIGHT EYE VISION LOSS ON THE SURGEON'S CONSOLE. THE PATIENT'S PROSTATECTOMY PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON WAS UNABLE TO VIEW THE RIGHT EYE IN THE SURGEON'S CONSOLE AT THE START OF A DA VINCI SI PROSTATECTOMY PROCEDURE. THE PATIENT WAS NOT DOCKED TO THE DA VINCI SYSTEM YET WHEN THE REPORTED ISSUE WAS OBSERVED. THE SURGICAL STAFF CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT TO REPORT THE ISSUE AND FOR TROUBLESHOOTING. THE ISI TECH SUPPORT REPRESENTATIVE WALKED THE CUSTOMER THROUGH REMOVING THE INSTRUMENTS AND PERFORMING A POWER CYCLE. THE SYSTEM POWERED UP WITH THE ERROR 48200 WITH THE RIGHT EYE STILL OUT ON THE SURGEON'S CONSOLE. THE CUSTOMER VERIFIED THAT BOTH RIGHT AND LEFT EYE AT THE VISION CART TOUCHSCREEN WAS WORKING. SINCE THE SURGEON WAS NOT COMFORTABLE CONDUCTING THE PROSTATECTOMY WITHOUT THE RIGHT EYE OF THE SURGEON'S CONSOLE SO THE SURGEON DECIDED TO CONVERT TO AN OPEN SURGICAL PROCEDURE. THE CUSTOMER CONFIRMED THAT THE PROSTATECTOMY WAS COMPLETED. ON (B)(6) 2013, AN ISI FIELD SERVICE REPRESENTATIVE VISITED THE SITE AND VERIFIED THE RIGHT VIDEO LOSS ON THE SURGEON'S CONSOLE AND THE ERROR IN THE SYSTEM LOGS. THE REPORTED ISSUES WERE RESOLVED BY REPLACING THE PMSC (PERSONALITY MODULE SURGEON CONSOLE) COMPONENT OF THE SURGEON'S CONSOLE. ON (B)(6) 2013, ISI REPRESENTATIVE SPOKE WITH THE INITIAL REPORTER. SHE INDICATED THAT THE VISION ISSUES OCCURRED AFTER CONNECTING AN ULTRASOUND DEVICE OR THE DA VINCI SIMULATOR TO THE DA VINCI SURGEON'S CONSOLE. SHE CONFIRMED THAT THE SITE HAS PERFORMED SUBSEQUENT SURGERIES WITH NO ISSUES AFTER THE PART WAS REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516737 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES