BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1880690 · Received October 25, 2010

    Report

    Report Number
    2955842-2010-00459
    Event Type
    Other
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODES EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM, A MASTER TOOL MANIPULATOR (MTM) ARM, A SET UP JOINT (SUJ), AND TWO REMOTE ARM CONTROLLERS (RAC). THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE MTM 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 SETUP JOINT IS THE PRINTED CIRCUIT ASSEMBLY (PCA) INSIDE A SYSTEM ARM THAT MONITORS THE ENCODER FOR EACH OF FOUR JOINTS AND THEIR ASSOCIATED BACKUP POTENTIOMETERS. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY BOARDS (PCA) WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM, MTM, SUJ, AND RACS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 25553 IS REPORTED WHEN THE DA VINCI SAFETY SYSTEM DETERMINES A HARDWARE FAULT REACTION LOGIC OCCURRED ON A LOCAL RAC. SYSTEM ERROR CODE 23009 IS REPORTED WHEN THE DA VINCI SAFETY SYSTEMS DETERMINED 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 DAVINCI IN A RECOVERABLE SAFE STATE. THE COMPONENTS WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS ABLE TO REPLICATE THE ERROR 23009 ON THE ECM. NO TROUBLE WAS FOUND ON THE MTM, TWO RACS OR THE SUJ. 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 WHILE BEGINNING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED A NON RECOVERABLE SYSTEM ERROR 25553. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER POWER CYCLED THE SYSTEM. THE SYSTEM DID NOT ERROR UPON RESTART, HOWEVER, THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT INCISIONS WERE MADE WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AND RESCHEDULE FOR A LATER DATE. 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 A6.0P5

    Patients

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