BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 2324939 · Received November 4, 2011

    Report

    Report Number
    2955842-2011-00347
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE 20008 WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) 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 SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML GIMBAL. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED. SYSTEM ERROR CODE 20008 OCCURS WHEN THE DA VINCI SAFETY SYSTEM DETERMINES 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 SYSTEM RECORDS THE FAULT AND TRANSITIONS TO A SAFE STATE. THE MTML GIMBAL WAS RETURNED TO INTUITIVE SURGICAL FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS ABLE TO REPLICATE THE REPORTED FAILURE DURING INTERNAL TESTING AND DETERMINED THAT AN AXIS POTENTIOMETER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD JUST SAT DOWN AT THE SURGEON CONSOLE TO BEGIN A DA VINCI PROSTATECTOMY PROCEDURE WHEN SYSTEM ERROR CODE 20008 OCCURRED. TO CLEAR THE ERROR, THE SURGICAL STAFF POWERED DOWN THE SYSTEM, BACK DROVE THE LEFT MASTER TOOL MANIPULATOR GIMBAL, AND RESTARTED THE SYSTEM. AFTER RESTARTING THE SYSTEM, THE SAME ERROR CODE RECURRED. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT INCISIONS HAD BEEN MADE WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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 ACCESSORIES