BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1061710 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01077
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODE #297 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 THE FOUR JOINTS AND THEIR ASSOCIATED BACKUP POTENTIOMETERS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CFG ESSJ AND RECONNECTING THE LOW VOLTAGE DIFFERENTIAL SIGNAL (LVDS) CABLE TP THE PCA. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYSTEM ERROR CODE #23 INDICATES A COMMUNICATION FAILURE BETWEEN THE SURGEON CONSOLE AND THE PT SIDE CART AND THIS COMMUNICATION FAILURE CAUSED AN INCOMPLETE PCA SOFTWARE DOWNLOAD WHICH CREATED THE PERSISTENT FAULT CONDITION ERROR CODE OF #297. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE SETTING UP THE DA VINCI S SURGICAL SYSTEM FOR A PROSTATECTOMY PROCEDURE THE CUSTOMER EXPERIENCED SYSTEM ERROR CODE #297. THE CUSTOMER RESTARTED THE SYSTEM, HOWEVER, SYSTEM ERROR CODE #297 RECURRED UPON POWER UP. THE PT WAS UNDER ANESTHESIA AND THE PORT INCISIONS HAD BEEN CREATED WHEN THE SITE DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY. 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 ACCESSORIES| DA VINCI S SURGICAL SYSTEM| INSTRUMENTS