BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3093014 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01551
    Event Type
    Other
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE 23000 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 23000 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 THE MTML GIMBAL'S AXIS 6 POTENTIOMETER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. ENGINEERING EVALUATION ALSO FOUND THAT THE HARD PIN ON THE AXIS 6 LINK WHERE THE AXIS 7 LINK IS ATTACHED HAD SLIPPED LOWER INTO THE HOUSING, WHICH ALLOWED THE AXIS 7 LINK TO GO BEYOND THE CALIBRATED HARD STOP. THE AXIS 6 WAS REPLACED TO REPAIR THE MTML GIMBAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SACROCOLPOPEXY PROCEDURE, WHEN THE SYSTEM WAS POWERED ON, THE SITE EXPERIENCED SYSTEM ERROR CODE 23000. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) THE SITE PERFORMED AN EMERGENCY POWER OFF (EPO) OF THE SYSTEM AND CYCLED THE SYSTEM BREAKERS; HOWEVER, SYSTEM ERROR CODE 23000 RECURRED. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT THE SYSTEM ERROR CODE 23000 EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) ON THE SURGEON SIDE CART. THE TSE INSTRUCTED THE SITE TO PERFORM ADDITIONAL TROUBLESHOOTING TECHNIQUES; HOWEVER, THE ISSUE PERSISTED. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT INCISIONS HAD BEEN CREATED WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULED IT FOR A LATER DATE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195371 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A51P.8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE