BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4133735 · Received October 1, 2014

    Report

    Report Number
    2955842-2014-05423
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM FROM PART NUMBER (B)(4), SERIAL NUMBER (B)(4) WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORT FAILURE MODE. DURING A WEIGHTED BRAKE DROP TEST OF THE PSM, SYSTEM ERROR CODE 23022 WAS GENERATED AND FOUND TO BE ASSOCIATED WITH THE PSM'S AXIS 2 BRAKE. AXIS 2 WAS REPLACED TO REPAIR THE PSM. AXIS 1 WAS REPLACED AS A PRECAUTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND IN THE DA VINCI SI SYSTEM LOGS AND NO PATIENT INVOLVEMENT OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    UPON REVIEW OF THE DA VINCI SI SYSTEM LOG REVIEW, AN INTUITIVE SURGICAL INC. (ISI) REPRESENTATIVE OBSERVED AN 23022 ERROR MESSAGE INDICATING THAT A BRAKE FAULT ON A PATIENT SIDE MANIPULATOR (PSM) OCCURRED. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE PSM WAS REPLACED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE OUTCOMES. ON (B)(4)2014, A FIELD INVESTIGATION WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE). THE FSE DETERMINED THAT THE SYSTEM ERROR CODE 23022 WAS ASSOCIATED WITH PSM 3. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611110 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1