BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4301277 · Received December 5, 2014

    Report

    Report Number
    2955842-2014-05797
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED TO INTUITIVE SURGICAL INC. (ISI) FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PSM FAILED THE WEIGHTED BRAKE TEST. THE AFFECTED PSM WAS REPLACED. THE AXIS-2 WAS REPLACED TO CORRECT THE PROBLEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR (PSM) FAILING THE WEIGHTED BRAKE TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND DURING PREVENTIVE MAINTENANCE 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 3 WAS REPLACED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787420 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P8

    Patients

    Seq Age Sex Outcome Treatment
    1