BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1172653 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01272
    Event Type
    Other
    Date Received
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE #23023 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM). THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, THE PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. SYSTEM ERROR CODE #23023 APPEARS WHEN THE DAVINCI SAFETY SYSTEM DETERMINES THAT THE POWER SENSE SIGNAL ON THE CANNULA IS NOT AS EXPECTED. SIGNALING THAT THE CANNULA SENSOR SIGNAL CANNOT BE TRUSTED. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUT DAVINCI IN A "RECOVERABLE SAFE STATE". THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING DISCOVERED THAT THE EMBEDDED SERIALIZER PATIENT MANIPULATOR (ESPM) BOARD, WHICH MONITORS THE STATUS OF LOGIC SIGNALS FROM THE EXTERNAL PUSH BUTTON SWITCHES AND THE CANNULA ID SENSORS, HAD MALFUNCTIONED AND CAUSED THE CANNULA SENSORS TO WORK INCORRECTLY, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. 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 WHILE SETTING UP THE DA VINCI S SURGICAL SYSTEM FOR A PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE #23023. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL TECHNICAL SUPPORT ENGINEER, THE SITE RECYCLED POWER TO THE SYSTEM BUT THE SYSTEM ERROR CODE REMAINED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SITE DECIDED TO ABORT THE 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 A5.1P4

    Patients

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