BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1071753 · Received July 9, 2008

    Report

    Report Number
    2955842-2008-01140
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODES # 903 AND #40006 EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH THE REMOTE ARM CONTROLLER (RAC) FOR THE ECM AND/OR THE CABLE CONNECTING THE SSC TO THE PSC. THE ECM IS THE SYSTEM CAMERA ARM LOCATED ON THE PSC WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE RAC CONSISTS OF FIVE PCAS WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RAC AND CABLE. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYSTEM ERROR CODE #903 IS AN INDICATION THAT THE ERROR LOG IS FULL AND SYSTEM ERROR CODE # 40006 APPEARS WHEN AN ATTEMPT IS MADE TO INSERT AN ELEMENT INTO A FULL QUEUE. THE VISION CABLE AND RAC WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING FOUND NO ISSUES WITH THE RAC, HOWEVER, IT WAS OBSERVED THAT A VISION CABLE FIBER CONTACT HAD MAJOR CONTAMINATION, WHICH MAY HAVE CAUSED A SYSTEM COMMUNICATION FAULT THUS LEADING TO THE ERROR LOG/QUEUE OVERFLOWS THAT WERE INDICATED BY THE ERROR CODES. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE THE CUSTOMER EXPERIENCED A SYSTEM ERROR AND POWERED DOWN THE SYSTEM. ON POWER UP, THE LED OF THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM WAS RED AND SYSTEM ERROR CODE # 903 APPEARED. THE CUSTOMER POWERED DOWN THE SYSTEM FOR A SECOND TIME AND RECYCLED THE POWER ON THE SURGEON SIDE CONSOLE (SSC) AND PT SIDE CART (PSC). THE SYSTEM WAS THEN RESTARTED AND SYSTEM ERROR CODE # 40006 APPEARED. THE SYSTEM WAS SHUTDOWN AND RESTARTED FOR A THIRD TIME, HOWEVER, THE SYSTEM WOULD NOT COMPLETE START UP AND SYSTEM ERROR CODE # 903 RECURRED. THE PT HAD BEEN UNDER ANESTHESIA FOR APPROX 3 HOURS WHEN THE SURGEON DECIDED TO CONVERT TO AN OPEN SURGICAL TECHNIQUE TO COMPLETE THE PLANNED PROCEDURE. NO PT 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 A5.1P4

    Patients

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