BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1408773 · Received June 26, 2009

    Report

    Report Number
    2955842-2009-00201
    Event Type
    Other
    Date Received
    June 26, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 2, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) GIMBLE. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM ARM, CONSISTING OF THE LINKS ASSOCIATED WITH THE FIVE AXES OF MOTION CLOSEST TO THE SURGEON'S HAND. THESE AXES MEASURE THE ORIENTATION OF THE MTM HANDLE AND THE MTM GRIP ANGLE. THE GIMBAL IS SEPARATED FROM THE REST OF THE MTM BY REMOVING THE PLATFORM LINK FROM THE FOREARM LINK. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTM GIMBLE. THE MTML GIMBLE WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION OF THE MTML GIMBLE FOUND A MISSING SPRING ON AXIS-8, THUS CONFIRMING THE REPORTED COMPLAINT EXPERIENCED BY THE CUSTOMER. AS OF JUNE 25, 2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGEON EXPERIENCED STIFFNESS IN THE PATIENT SIDE MANIPULATOR (PSM) ARM GRIP CLOSURE AND RESISTANCE IN THE MASTER TOOL MANIPULATOR (MTM) GRIP MOVEMENT. THE SURGEON WAS UNABLE TO CONTROL INSTRUMENT CLOSURE. THE SURGEON DECIDED 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 A5.1P7

    Patients

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