BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4224204 · Received November 4, 2014

    Report

    Report Number
    2955842-2014-05598
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 7, 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 AND BRAKE WAS UPGRADED. THE AXIS-1 WAS REPLACED TO CORRECT THE PROBLEM. THE PSM PASSED THE BASIC FRICTION TEST AND VISCOUS TEST. 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

    DURING THE PREVENTATIVE MAINTENANCE OF THE DA VINCI SI SURGICAL SYSTEM BY THE INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE), IT WAS OBSERVED THAT THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 FAILED THE FRICTION THE VISCOUS DRAG TESTS. NO PATIENT INVOLVEMENT OR IMPACT OCCURRED. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM ARM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708035 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P8

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES