BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1584466 · Received January 15, 2010

    Report

    Report Number
    2955842-2010-00019
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE DUPLICATE THE ERROR CODE #23008, HOWEVER, AS A PRECAUTION, THE FSE REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTM) GIMBAL. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM, 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 SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYSTEM ERROR CODE #23008 APPEARS WHEN THE DA VINCI S SAFETY SYSTEMS DETERMINES THAT THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI S IN A "NONRECOVERABLE SAFE STATE". THE MTM GIMBAL WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING EVALUATION FOUND THAT THE AXIS POTENTIOMETER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. THE AXIS POTENTIOMETER WAS REPLACED. AS OF (B)(4) 2010 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSP.

    Description of Event or Problem · 1

    THE ISI REP ON SITE REPORTED THAT DURING A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, MULTIPLE OCCURRENCES OF SYSTEM ERROR CODE #23008 WERE EXPERIENCED. WITH THE ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER, THE SITE WAS INSTRUCTED TO EXERCISE THE AXIS OF THE RIGHT AND LEFT MASTER TOOL MANIPULATORS (MTM) WHEN ERROR CODE #23008 RECURRED, HOWEVER, WHEN THE ERROR CODE RECURRED, THE SITE WAS UNABLE TO EXERCISE THE AXES OF THE MTM. THE SITE POWER CYCLED THE SYSTEM, HOWEVER, WHEN THE SYSTEM POWERED UP AND HOMED, THE SYSTEM ERROR CODE #23008 RECURRED. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PT 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 ACCESSORIES| DVS| INSTRUMENTS