BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1711231 · Received June 4, 2010

    Report

    Report Number
    2955842-2010-00237
    Event Type
    Other
    Date Received
    June 4, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONFIRMED THAT SYSTEM ERROR CODE 20008 OCCURRED. ENGINEERING ALSO FOUND SYSTEM ERROR CODE 21008 PRESENT IN THE SYSTEM ERROR LOGS. ENGINEERING DETERMINED THAT THESE SYSTEM ERRORS WERE ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) 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 WAS REPAIRED BY REPLACING THE AFFECTED MTML GIMBAL. THE SYSTEM ALARMS (SYSTEM GENERATED FAULT CODES) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODES 20008 AND 21008 APPEAR WHEN THE DA VINCI 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. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUTS DA VINCI IN A RECOVERABLE SAFE STATE. THE MTML GIMBAL WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DISCOVERED THAT A SCREWS HAD BROKEN, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER AND PREVENTING THE SYSTEM FROM HOMING. AS OF JUNE 3, 2010, 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 GYNECOLOGICAL PROCEDURE, THE CUSTOMER EXPERIENCED SYSTEM ERROR CODE 20008. THE SITE UNDOCKED THE SYSTEM FROM THE PATIENT AND RESTARTED THE SYSTEM. THE LEFT MASTER TOOL MANIPULATOR (MTM) WAS NOT FREE TO HOME AND WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE EXERCISED THE LEFT MASTER. THIS DID NOT RESOLVE THE PROBLEM AS SYSTEM ERROR 20008 FAULT RETURNED. THE SITE THEN POWERED DOWN THE SYSTEM, RESET THE BREAKER, PRESSED EMERGENCY POWER OFF, AND EXERCISED AXIS 2 OF THE LEFT MTM FOR APPROXIMATELY 30 SECONDS. ONCE THE SYSTEM WAS RESTARTED, THE SYSTEM CONTINUED TO EXPERIENCE ISSUES HOMING AND SYSTEM ERROR CODE 20008 RETURNED. AT THIS TIME, THE SURGEON MADE THE DECISION 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SYSTEM INSTRUMENTS, ACCESSORIES & ESU