BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2222297 · Received August 24, 2011

    Report

    Report Number
    2955842-2011-00274
    Event Type
    Other
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE 23007 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE A GIMAL ON THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). 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. THE 23007 SYSTEM ERROR CODE APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THE RATE OF CHANGE IN 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), ARE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEMS PUT DA VINCI S IN A RECOVERABLE SAFE STATE. THE MTMR GIMBAL WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING FOUND THE AXIS 7 BEVEL GEAR CLAMP TO HAVE A BROKEN SCREW, WHICH WAS STUCK BETWEEN THE AXIS 7 GEAR CAUSING IT TO STICK. THE AXIS 7 GEAR CLAMP 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 SI PROSTATECTOMY PROCEDURE, WHILE CHANGING INSTRUMENTS, THE CUSTOMER EXPERIENCED SYSTEM ERROR CODE 23007. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) THE SITE RESTARTED THE SYSTEM MULTIPLE TIMES AND EXERCISED THE RIGHT MASTER TOOL MANIPULATOR (MTMR), HOWEVER, THE SYSTEM ERROR CODE REOCCURRED. THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE, HOWEVER TO PROVIDE THE PATIENT WITH WATER TIGHT ANASTOMOSUS, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES