BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1487676 · Received September 18, 2009

    Report

    Report Number
    2955842-2009-00304
    Event Type
    Other
    Date Received
    September 18, 2009
    Date of Event
    August 21, 2009
    Report Date
    August 21, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND SYSTEM ERROR CODE #23017 AND SYSTEM ERROR CODE #25588 TO BE ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM) ARM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. 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." SYSTEM ERROR CODE #25588 IS A SYMPATHETIC ERROR AND OCCURS DURING THE SELF TEST UPON SYSTEM POWER UP WHEN A LOOP RESPONSE TEST FAILS. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED A PROBLEM AND FOUND THE PSM FAULTED IMMEDIATELY. THE PSM AXIS 2 MOTOR ENCODER WAS REPLACED AND AXIS 2 AND AXIS 4 POTENTIOMETERS WERE REPLACED. AS OF SEPTEMBER 17, 2009, 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 S HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED UNRECOVERABLE SYSTEM ERROR CODE #23017 AND ONE OF THE PATIENT SIDE MANIPULATOR (PSM) ARMS LED WAS LIT RED. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE POWER CYCLED THE SYSTEM, HOWEVER UPON RESTARTING, SYSTEM ERROR CODE #25588 OCCURRED. THE TSE HAD THE SITE EMERGENCY POWER OFF THE SYSTEM, CYCLE THE BREAKERS ON THE SURGEON SIDE CART (SSC) AND PATIENT SIDE CART (PSC), HOWEVER UPON POWERING UP, THE SYSTEM ERROR CODE #25588 RECURRED. THE TSE HAD THE SITE UNDRAPE THE AFFECTED PSM AND STOW THE ARM, EMERGENCY POWER OFF THE SYSTEM, AND CYCLE THE SSC AND PSC BREAKERS, HOWEVER, THE SYSTEM ERROR CODES CONTINUED TO OCCUR. APPROXIMATELY 30 MINUTES INTO THE PROCEDURE, 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 S5.1P7

    Patients

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