BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1408777 · Received June 26, 2009

    Report

    Report Number
    2955842-2009-00205
    Event Type
    Other
    Date Received
    June 26, 2009
    Date of Event
    June 4, 2009
    Report Date
    June 4, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE #23008 AND #212 WERE 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 MTML GIMBLE. THE SYSTEM ALARMS (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE #23008 APPEARS WHEN THE DA VINIC S SAFETY SYSTEM 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. SYSTEM ERROR CODE #212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUTS DA VINCI IN A "RECOVERABLE SAFE STATE". THE MTML GIMBLE WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING WAS NOT ABLE TO REPRODUCE THE CUSTOMER REPORTED PROBLEM, HOWEVER, AS A PRECAUTION, AXIS 7 POTENTIOMETER AND THE MOTOR/ENCODER ASSEMBLY WERE REPLACED. 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 THE BEGINNING OF A DA VINCI S SURGICAL PROCEDURE THE SITE EXPERIENCED SYSTEM ERROR #23008 DURING SYSTEM HOMING. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE ATTEMPTED TO EXERCISE AXIS 7 ON THE LEFT MASTER TOOL MANIPULATOR (MTML) WITHOUT SUCCESS. THE SITE THEN POWERED DOWN THE SYSTEM, EXERCISED THE AXIS, AND RESTARTED THE SYSTEM, HOWEVER, SYSTEM ERROR #212 APPEARED. THE SYSTEM WAS THEN POWERED DOWN, THE BREAKER WAS RESET, AND THE SURGEON SIDE CONSOLE (SSC) HAD THE EMERGENCY POWER OFF (EPO) BUTTON APPLIED BEFORE RESTARTING THE SYSTEM. AT THIS TIME SYSTEM ERROR #23008 RE-APPEARED DURING HOMING. THE PATIENT HAD BEEN UNDER ANESTHESIA FOR APPROXIMATELY 30 MINUTES WITH PORTS PLACED WHEN THE SURGEON DECIDED TO CONVERT TO TRADITIONAL 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 INSTRUMENTS| DA VINCI S SURGICAL SYSTEM| ACCESSORIES