BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1902722 · Received November 12, 2010

    Report

    Report Number
    2955842-2010-00497
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE #21008 WAS ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR) GIMBAL. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM, CONSISTING OF THE LINKS ASSOCIATED WITH THE FIVE AXES OF MOTION CLOSEST TO THE SURGEON'S HAND. THESE AXES MEASURE THE ORIENTATION OF THE MTM HANDLE AND THE MTM GRIP ANGLE. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTMR GIMBAL. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE #21008 APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETERMINES THAT THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUTS DA VINCI IN A "RECOVERABLE SAFE STATE." THE MTMR GIMBAL WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DISCOVERED THAT AN AXIS POTENTIOMETER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. AS OF NOVEMBER 10, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USING THE DA VINCI SURGICAL SYSTEM TO PERFORM ANY SURGICAL TASKS FOR A PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED MULTIPLE OCCURRENCES OF SYSTEM ERROR CODE #21008. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE. 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 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other