BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1512252 · Received October 9, 2009

    Report

    Report Number
    2955842-2009-00324
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    September 9, 2009
    Report Date
    September 9, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) CONCLUDED THAT SYSTEM ERROR CODES #21013 AND #21008 EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH A PT SIDE MANIPULATOR (PSM) ARM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE FSE ALSO FOUND ERROR CODE #21008, ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR) GIMBAL, IN THE SYSTEM ERROR LOGS. 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 WAS REPAIRED BY REPLACING THE AFFECTED PSM AND MTMR GIMBAL. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYSTEM ERROR CODES #21013 AND #21008 APPEAR WHEN THE DA VINCI SAFETY SYSTEM DETERMINES A DIFFERENTIAL CHANGE IN 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), ARE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEM PUTS DA VINCI IN A "NONRECOVERABLE SAFE STATE." THE PSM AND MTMR GIMBAL WERE RETURNED TO ISI FOR EVAL. ENGINEERING DETERMINED THAT AN ENCODER HAD MALFUNCTIONED ON THE PSM AND AXIS POTENTIOMETER HAD MALFUNCTIONED ON THE MTMR GIMBAL, THUS GENERATING THE SYSTEM ERROR CODES EXPERIENCED BY THE CUSTOMER. AS OF 10/01/2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED MULTIPLE OCCURRENCES OF SYSTEM ERROR CODES #21013 AND #21008. 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P9

    Patients

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