BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1002861 · Received February 12, 2008

    Report

    Report Number
    2955842-2008-00053
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 11, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION CONDUCTED BY FIELD SVC ENGINEERING CONCLUDED THAT SYS ERROR CODE #25589 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE REMOTE ARM CONTROLLER (RAC). THE RAC CONSISTS OF 5 PCAS THAT PROVIDE CONTROL OF THE SYS INSTRUMENT AND CAMERA ARMS. THE SYS WAS REPAIRED BY REPLACING THE AFFECTED RAC. THE SYS ALARM (SYS GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYS ERROR CODE #25589 APPEARS WHEN THE DA VINCI S SAFETY SYS DETERMINES THAT THE BRAKES FAILED THE BRAKE VOLTAGE TEST DURING THE RAC POWER UP SELF TEST. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT THE DA VINCI S IN A "RECOVERABLE SAFE STATE." THE RAC WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. INSPECTION WAS PERFORMED AND FAULTY CHIPS ON THE DRIVE MODULES WERE REPLACED TO REPAIR THE RAC. 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 PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NON-RECOVERABLE SYS ERROR CODE #25589. NO PT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY.

    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 SYS INSTRUMENTS