BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1022531 · Received March 25, 2008

    Report

    Report Number
    2955842-2008-00145
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 21, 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

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE #212 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RIGHT MTM. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE #212 APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETERMINES A VOLTAGE TRACKING FAULT REPORTED BY THE DIGITAL SIGNAL PROCESSOR (DSP). UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEM PUT DA VINCI IN A "NON-RECOVERABLE SAFE STATE". THE RIGHT MTM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONCLUDED THAT AN AXIS MOTOR AND ENCODER ASSEMBLY HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR EXPERIENCED BY THE CUSTOMER. THE RESCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED THE SAME DAY THE AFFECTED MTMR WAS REPLACED. 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 DURING THE START OF A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NON-RECOVERABLE SYSTEM ERROR CODE #212. THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE. THE PATIENT INCISIONS WERE CLOSED AND THE CASE WAS RESCHEDULED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P8

    Patients

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