BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4211651 · Received October 29, 2014

    Report

    Report Number
    2955842-2014-05569
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) ARM 2 WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING FOUND THAT THE PSM ARM 2 PASSED SINE CYCLE AND SLOW SWEEP, BUT FAILED THE IN-HOUSE BRAKE DROP TEST. THE AXIS-2 BRAKE, AXIS-2 GEARS, BRAKE BEARINGS AND BRAKE SHAFT WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR ARM FAILING THE BRAKE WEIGHT DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND DURING FAILURE ANALYSIS 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

    IT WAS REPORTED THAT DURING MULTIPLE DA VINCI SURGICAL PROCEDURES, THE SURGEON NOTED MOVEMENT OF INSTRUMENTS IN ARM 2 WERE STICKING AND JERKING. ARM 3 HAD NOT BEEN USED AND WAS CURRENTLY DOCKED. THE SURGEON SWITCHED TO PATIENT SIDE MANIPULATOR (PSM) ARM 3 CONTROLED BY MASTER TOOL MANIPULATOR (MTM) AND IT FELT NORMAL. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692128 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P8

    Patients

    Seq Age Sex Outcome Treatment
    1