BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1081625 · Received July 16, 2008

    Report

    Report Number
    2955842-2008-01142
    Event Type
    Other
    Date Received
    July 16, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODE #23 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A CONFIGURED EMBEDDED SERIALIZER SETUP JOINT (CFG, ESSJ). THE EMBEDDED SERIALIZER FOR SETUP-JOINT IS THE PRINTED CIRCUIT ASSEMBLY (PCA) INSIDE A SYSTEM ARM THAT MONITORS THE POTENTIOMETER FOR EACH OF FOUR JOINTS AND THEIR ASSOCIATED BACKUP POTENTIOMETERS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CFG ESSJ. SYSTEM ERROR CODE #23 IS REPORTED BY SOFTWARE TO DENOTE THAT THE HARDWARE WHEEL "WDOG" HAS TRIPPED ON ONE OF THE DIGITAL COMMUNICATION LINKS IN THE SYSTEM. THIS MEANS THAT THE SYSTEM CANNOT RELIABLY COMMUNICATE OVER THE DIGITAL LINK AND THEREFORE CANNOT CONTINUE NORMAL OPERATION. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE PROCEDURE WAS ABORTED. AS OF 2007, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING THE DA VINCI S SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A SYSTEM ERROR CODE #23. THE PATIENT HAS BEEN UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE IT TO A LATER DATE. 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