BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1202909 · Received October 17, 2008

    Report

    Report Number
    2955842-2008-01325
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE #23017 EXPERIENCED BY THE CUSTOMER, WAS ASSOCIATED WITH THE 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. THE SYSTEM ERROR CODE APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT THE MOTOR DID NOT RESPOND AS EXPECTED. THIS OCCURS WHEN THE MEASURED VOLTAGE DOES NOT MATCH THE INTERNAL SIMULATION OF THE MOTOR CIRCUIT. THIS CAN BE CAUSED BY AN ENCODER FAILURE, AMPLIFIER FAILURE, OR MOTOR AND OR MOTOR LEAD PROBLEMS. SPORADIC FAULTS MAY BE CAUSED BY AGING BRUSHES INSIDE THE MOTOR. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEM PUT DA VINCI S IN A "RECOVERABLE SAFE STATE." THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION, HOWEVER, THE FAULT EXPERIENCED BY THE CUSTOMER COULD NOT BE DUPLICATED. BASED ON THE SYSTEM ERROR LOGS, THE AXIS 4 POTENTIOMETER AND MOTOR ASSEMBLY WERE REPLACED. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE HOURS INTO A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED MULTIPLE OCCURRENCES OF SYSTEM ERROR CODE #23017. THE SYSTEM ERROR RECURRED AFTER SEVERAL SYSTEM RESTARTS. THE PATIENT WAS KEPT UNDER ANESTHESIA APPROXIMATELY AN ADD'L 30 MINUTES WHILE TROUBLESHOOTING THE REPORTED PROBLEM AND, PREPARING THE SITE'S SPARE DA VINCI SURGICAL SYSTEM TO FINISH THE PLANNED SURGERY. 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 A5.1P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI S SURGICAL SYSTEM INSTRUMENTS