BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 739066 · Received July 19, 2006

    Report

    Report Number
    2955842-2006-00078
    Event Type
    Other
    Date Received
    July 19, 2006
    Date of Event
    July 7, 2006
    Report Date
    July 7, 2006
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM FAULT EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE SYSTEM WAS EAPAIRED BY REPLACING THE AFFECTED ECM. THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING DISCOVERED THAT THE MOTOR ENCODER ASSEMBLIES HAD MALFUNCTIONED ON TWO AXES, THUS GENERATING THE SYSTEM ERRORS EXPERIENCED BY THE CUSTOMER. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. AS OF JULY 19, 2006, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED UNRECOVERABLE 23015 SYSTEM ERROR CODE. 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM KOG INTUITIVE SURGICAL, INC. IS2000 A5. 0P3 SG019

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other