BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4250959 · Received November 14, 2014

    Report

    Report Number
    2955842-2014-05670
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    November 2, 2014
    Report Date
    November 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS RETURNED TO INTUITIVE SURGICAL INC., (ISI) FOR FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS FOUND THE PSM FAILED THE WEIGHTED BRAKE DROP TEST. FAILURE ANALYSIS CONFIRMED THE BRAKE FAILURE ALONG AXIS 2. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND DURING PREVENTATIVE MAINTENANCE AND NO PATIENT INVOLVEMENT OCCURRED, IF THE 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 A DA VINCI SURGICAL SYSTEM BY THE INTUITIVE SURGICAL, INC. REPRESENTATIVE OR FIELD SERVICE ENGINEER (FSE), IT WAS RECOGNIZED THAT ONE OF THE PATIENT SIDE MANIPULATORS (PSMS) FAILED THE FRICTION TEST. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736771 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1