BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1120674 · Received August 14, 2008

    Report

    Report Number
    2955842-2008-01166
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    May 9, 2008
    Report Date
    August 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT SYSTEM ERROR CODE #212 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) AND/OR A MULTIPLE SERVO DRIVER (MSD) PCA BOARD. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO THEIR RIGHT (MTMR). THE SYSTEM CONTAINS FIVE MULTIPLE SERVO DRIVER (MSD) BOARDS WHICH PROVIDE DRIVE CURRENT TO THE SERVO MOTORS ASSOCIATED WITH EACH DEGREE OF FREEDOM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML AND MSD PCA. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE #212 SYSTEM ERROR CODE APPEARS WHEN THE DAVINCI S SAFETY SYSTEM DETECTS AN ERROR IN THE EXPECTED MOTOR CURRENT AND VOLTAGE VALUES. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DAVINCI S IN A "RECOVERABLE SAFE STATE". THE MTML AND MSD PCA WERE RETURNED FOR EVAL. NO ISSUES WERE FOUND WITH THE MSD PCA, HOWEVER, ENGINEERING WAS ABLE TO REPLICATE SYSTEM ERROR CODE #212 DURING TESTING OF THE MTML. FURTHER EVAL OF THE MTML REVEALED THAT AN ELECTRICAL CABLE/HARNESS HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCE OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NONRECOVERABLE SYSTEM ERROR CODE #212. AN ISI TECHNICAL SUPPORT ENGINEER ATTEMPTED TO TROUBLESHOOT THE ISSUE VIA TELEPHONE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED AND THE PLANNED SURGICAL PROCEDURE WAS ABORTED AND RESCHEDULED FOR 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