BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1031785 · Received April 15, 2008

    Report

    Report Number
    2955842-2008-00196
    Event Type
    Other
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 11, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING (FSE) DISCOVERED THE VISION SYSTEM TO BE WITHIN SPECIFICATION. THE FSE CONFIRMED THE SURGEON SIDE CONSOLE (SSC) CAMERA CONTROL UNIT (CCU) SETTINGS WERE CORRECT AND VERIFIED THE LIGHT OUTPUT FROM THE ILLUMINATOR. THE SURGEON SIDE CONSOLE IS THE CONTROL CENTER WHERE THE OPERATOR SITS OUTSIDE THE STERILE FIELD AND CONTROL INSTRUMENTS AND A 3D ENDOSCOPE WITH HIS/HER HANDS. THE ILLUMINATOR BULB WAS FOUND TO BE NEAR IT'S END OF LIFE WHICH MAY HAVE CONTRIBUTED TO THE REPORTED LACK OF LIGHT. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2.5 HOURS INTO A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON EXPERIENCED A LACK OF LIGHT IN THE SURGEON SIDE CONSOLE (SSC). NO PT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY. THE CUSTOMER CONTACTED ISI TECHNICAL SUPPORT AFTER THE PROCEDURE WAS COMPLETE.

    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 A5.1P4

    Patients

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