BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2110566 · Received June 1, 2011

    Report

    Report Number
    2955842-2011-00163
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS CONDUCTED BY A FIELD SERVICE ENGINEER (FSE) WHO WENT ONSITE AND EVALUATED THE SYSTEM. VISUAL AND MECHANICAL INSPECTIONS WERE PERFORMED WITH NO ISSUES FOUND. THE SYSTEM LOGS WERE REVIEWED AND NO ERRORS WERE OBSERVED. SYSTEM VERIFICATION TESTING WAS PERFORMED AND PASSED. THE FSE DEMONSTRATED TO THE SITE THAT THE INSTRUMENT WOULD CEASE FIRE THE INSTANT THE HEAD IS REMOVED FROM THE STEREO VIEWER. THE ROOT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. AS A PRECAUTION, THE FSE SWAPPED THE FOOD PEDAL ASSEMBLY. ADDITIONALLY, THE SITE'S BIOMEDICAL DEPARTMENT WILL REPLACE THE ELECTROSURGICAL UNIT AND ENERGY ACTIVATION CABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON RELEASED THE ENERGY CONTROL FOOT PEDAL AND REMOVED THEIR HEAD OUT OF THE STEREO VIEWER DURING A DA VINCI SI HYSTERECTOMY, THE SURGEON HEARD THE ELECTROSURGICAL UNIT (ESU) STILL RELEASING ENERGY. THE SURGEON PUT THEIR HEAD BACK INTO THE STEREO VIEWER AND NOTICED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT, WHICH WAS CONNECTED TO THE ESU, WAS RELEASING ENERGY. THE SURGEON TOOK CONTROL OF THE INSTRUMENT AND INADVERTENTLY TOUCHED FATTY TISSUE. THE SURGEON QUICKLY PRESSED THE FOOT PEDAL TO STOP THE INSTRUMENT FROM RELEASING ENERGY. IT WAS REPORTED THAT THE PATIENT SUFFERED A SMALL SUPERFICIAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MCS INSTRUMENT, VALLEYLAB FORCE FX ESU