BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2072734 · Received April 29, 2011

    Report

    Report Number
    2955842-2011-00130
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K060391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE 23008 WAS ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR) GIMBAL. 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 MTMR GIMBAL. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. 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 MTMR GIMBAL WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING CONFIRMED THAT THE CUSTOMER REPORTED FAILURE MODE WAS ASSOCIATED WITH A DEFECTIVE SENSOR ON AXIS 5 AND THE SENSOR WAS REPLACED. AS OF (B)(6) 2011, 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 HYSTERECTOMY PROCEDURE WHENEVER THE SURGEON MOVED A SPECIFIC PATIENT SIDE MANIPULATOR (PSM) ARM, SYSTEM ERROR 23008 WOULD APPEAR. 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 S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM, INSTRUMENTS ANS ACCESSORIES