BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4223213 · Received November 4, 2014

    Report

    Report Number
    2955842-2014-05584
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    2955842-11-11-2013-013-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING FOUND THAT THE AXIS-2 WAS SO STIFF AND COULD NOT PERFORM NORMAL TESTS IN PRETEST. THE AXIS-2 BRAKE WAS CAUSING THE ISSUE (PARTIALLY LOCKING UP), AND IT FAILED THE IN-HOUSE BRAKE DROP TEST AND THE SLOWSWEEP TEST. THE AXIS-2 BRAKE WAS REPLACED TO CORRECT THE PROBLEM. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR ARM FAILING THE SLOWSWEEP TEST DURING FAILURE ANALYSIS. ALTHOUGH 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 PREVENTIVE MAINTENANCE OF A DA VINCI SURGICAL SYSTEM BY THE INTUITIVE SURGICAL, INC. REPRESENTATIVE OR THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE PATIENT SIDE MANIPULATOR (PSM) ARM FAILED THE SLOWSWEEP AND THE BRAKE INSPECTION TEST. NO PATIENT INVOLVEMENT OR IMPACT OCCURRED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705637 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P8

    Patients

    Seq Age Sex Outcome Treatment
    1