BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1070712 · Received July 3, 2008

    Report

    Report Number
    2955842-2008-01117
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THE PATIENT SIDE MANIPULATOR (PSM) WAS HAVING INTERMITTENT ISSUES. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE #20008 SYSTEM ERROR CODES APPEARED WHEN THE DA VINCI SAFETY SYSTEM DETERMINED A DIFFERENTIAL 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) WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A "RECOVERABLE SAFE STATE". ENGINEERING CONCLUDED THE PSM ARM GENERATED THE SYSTEM ERROR WHEN ATTEMPTING TO RUN INTERNAL SYSTEM SENSOR CHECKS. ENGINEERING CONDUCTED TESTS FOR THE PSM AND CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SYSTEM WAS REPAIRED BY REPLACING THE MOTOR/ENCODER ON AXIS-3. AS OF JULY 01, 2008, 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 PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED A NON RECOVERABLE SYSTEM ERROR #20008. WITH THE ASSISTANCE OF AN ISI REPRESENTATIVE, THE CUSTOMER POWER CYCLED THE SYSTEM AND PLACED THE AFFECTED PATIENT SIDE MANIPULATOR (PSM) ARM OUT OF USE POSITION. THE CUSTOMER PROCEEDED WITH PROCEDURE, HOWEVER, THE NON-RECOVERABLE SYSTEM ERROR #20008 RECURRED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED PROCEDURE. A DELAY OF 30 MINUTES WAS NOTED. NO PATIENT HARM 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 INSTRUMENTS| ACCESSORIES