BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINICI SI SURGICAL SYSTEM

    MDR report key: 4194937 · Received October 22, 2014

    Report

    Report Number
    2955842-2014-05529
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM ARM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS CONFIRMED THE REPORTED FAILURE MODE. INSPECTION OF THE PSM FOUND THAT ONE OF THE MECHANICAL CABLES ALONG AXIS 7 WAS FRAYED. BOTH OF THE AXIS CABLES WERE REPLACED TO REPAIR THE PSM. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE PSM FAILED A WEIGHTED BRAKE DROP TEST. AXES BRAKE 1 AND BRAKE 2 WERE REPLACED TO REPAIR THE PSM. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT AND THE FAILURE MODE WAS FOUND DURING FAILURE ANALYSIS EVALUATION, 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 (PM) ON THE DA VINCI SURGICAL SYSTEM BY A FIELD SERVICE ENGINEER (FSE) IT WAS FOUND THAT THE AXIS 7 CABLE ON THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 WAS FRAYED. NO PATIENT INVOLVEMENT OR IMPACT OCCURRED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671779 DA VINICI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1