BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1891761 · Received November 5, 2010

    Report

    Report Number
    2955842-2010-00482
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) FOUND SYSTEM ERROR CODE 23017 AND 25511 TO BE ASSOCIATED WITH A ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM. ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT SIDE CART WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23017 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT A MOTOR DID NOT RESPOND AS EXPECTED AND THE MEASURED MOTION DID NOT MATCH THE INTERNAL SIMULATION OF THE MOTOR. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. ERROR CODE 25511 OCCURS ON STARTUP WHEN THE SYSTEM RUNS A DIAGNOSTIC TEST ON THE CURRENT CONTROL LOOP (WHICH REGULATES THE ELECTRIC CURRENT DRIVING MOTORS) AND DETERMINED IT TO BE OUT OF SPECIFICATION. WHEN THIS DIAGNOSTIC FAULT IS TRIGGERED, THE SYSTEM TRANSITIONS TO A NON-RECOVERABLE SAFE STATE. THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND FOUND THE ECM TO HAVE A DEFECTIVE MOTOR/ENCODER ASSEMBLY WHICH WAS REPLACED TO REPAIR THE ECM. AS OF (B)(4) 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BEGINNING OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED SYSTEM ERROR CODE 23017 ON A ENDOSCOPIC CAMERA MANIPULATOR(ECM) ARM. THE SITE RECYCLED POWER TO THE SYSTEM AND WHEN POWERING BACK ON, SYSTEM ERROR 25511 WAS EXPERIENCED. THE SITE UNDOCKED THE ECM, POWER SYSTEM DOWN AND EXERCISED THE ECM AXIS. THE SYSTEM POWERED UP AND HOMED SUCCESSFULLY. THE CUSTOMER ATTEMPTED TO DOCK THE ECM AND THE SYSTEM IMMEDIATELY FAULTED WITH SYSTEM ERROR CODE 23017. AT THIS TIME, THE SURGEON DECIDED 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 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM INSTRUMENT AND ACCESSORIES