BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2173978 · Received July 24, 2011

    Report

    Report Number
    2955842-2011-00231
    Event Type
    Other
    Date Received
    July 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND SYSTEM ERROR CODE 23017 AND 25588 IN THE SYSTEM ERROR LOGS. IT WAS DETERMINED THAT THESE ERRORS WERE ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM. 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. 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 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT A FLAT FLEX CABLE CONNECTING TO THE EMBEDDED SERIALIZER IN MASTER PLATFORM (ESPM) BOARD WAS NOT FULLY INSERTED. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A NON-RECOVERABLE SAFE STATE. THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND REPLACED THE MOTOR ENCODER AND FULLY INSERTED THE FLAT FLEX CABLE INTO THE ESPM TO REPAIR THE ECM. AS OF JULY 18, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BEGINNING OF A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED ERROR CODE 23017 AND THE ENDOSCOPIC CAMERA MANIPULATOR'S(ECM) LED WAS ILLUMINATED YELLOW. WITH THE ASSISTANCE OF A ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE ATTEMPTED TO TROUBLESHOOT THE ISSUE BY APPLYING EMERGENCY POWER OFF (EPO); HOWEVER, NON RECOVERABLE SYSTEM ERROR CODE 25588 OCCURRED. AT THIS TIME, THE DECISION WAS MADE TO PERFORM THE SURGERY USING TRADITIONAL OPEN TECHNIQUES. THERE WAS NO PATIENT INJURY 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 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENT, ACCESSORIES & ESU