BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1874383 · Received October 19, 2010

    Report

    Report Number
    2955842-2010-00443
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 19, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE TRANSFORMER LOCATED WITHIN ONE OF THE CAMERA CONTROL UNITS (CCU). THE CCUS CONTROL THE QUALITY OF THE VIDEO IMAGES AND PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI VISION SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. THE SYSTEM WAS REPAIRED BY REPLACING THE TRANSFORMER OF THE AFFECTED CCU. AS OF OCTOBER 19, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED NO VISION IN THE RIGHT SIDE MONITOR OF THE SURGEON'S CONSOLE. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES