BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1466298 · Received August 28, 2009

    Report

    Report Number
    2955842-2009-00286
    Event Type
    Other
    Date Received
    August 28, 2009
    Date of Event
    August 5, 2009
    Report Date
    August 5, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE #23008 WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) GIMBLE. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM ARM, 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 GIMBAL IS SEPARATED FROM THE REST OF THE MTM BY REMOVING THE PLATFORM LINK FROM THE FOREARM LINK. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTM GIMBLE. THE SYSTEM ALARM (SYSTEM GENERATE FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. SYSTEM ERROR CODE #23008 APPEARS WHEN THE DA VINCI S SAFETY SYSTEMS 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 SYSTEMS PUT DA VINCI S IN A "NONRECOVERABLE SAFE STATE". THE MTML GIMBLE WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVAL FOUND THE POTENTIOMETER PRODUCED A NOISY SIGNAL, LIKELY GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. AS AN ADD'L PRECAUTION, THE MOTOR AND ENCODER WERE ALSO REPLACED. AS OF 08/27/2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE #23008. THE SITE RECYCLED POWER TO THE SYSTEM AND BACK DROVE THE LEFT MASTER TOOL MANIPULATOR (MTML), HOWEVER, THE SYSTEM FAULT RECURRED. THE PT WAS UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURGICAL SYSTEMS INSTRUMENTS| DA VINCI S SURGICAL SYSTEMS ACCESSORIES