BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2132958 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00183
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND EVALUATED THE SYSTEM. VISUAL AND MECHANICAL INSPECTIONS WERE PERFORMED WITH NO ISSUES FOUND. SYSTEM VERIFICATION TESTING WAS PERFORMED AND PASSED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED. NO INFORMATION HAS BEEN RECEIVED WHICH SUGGESTS THAT THE DA VINCI S SURGICAL SYSTEM MALFUNCTIONED IN A WAY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. INTUITIVE SURGICAL CONCLUDED THAT THE PATIENT INJURY WAS UNRELATED TO THE PERFORMANCE OF THE DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ISOLATING THE PULMONARY VESSEL DURING A DA VINCI S THORACIC SYMPATHECTOMY PROCEDURE, A TEAR ON THE UNDERSIDE OF THE PATIENT'S PULMONARY VESSEL OCCURRED WHEN THE SURGEON PULLED ON A CALCIFIED LYMPH NODE. DUE TO THE LOCATION OF THE TEAR, THE SURGEON WAS UNABLE TO ANGLE THE SYSTEM CAMERA TO VIEW THE AFFECTED AREA, THEREFORE, UNABLE TO REPAIR THE ARTERY USING THE SYSTEM. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO REPAIR THE TEAR AND COMPLETE THE PLANNED PROCEDURE. THE DA VINCI PROCEDURE HAD BEEN IN PROGRESS FOR APPROX 2 HOURS WHEN THE EVENT OCCURRED. NO PATIENT IS REPORTEDLY DOING WELL AND NO POST SURGICAL COMPLICATIONS HAVE BEEN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O DA VINCI S SURGICAL SYSTEM, INSTS & ACCS