BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4152781 · Received October 8, 2014

    Report

    Report Number
    2955842-2014-05456
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. PATIENT SIDE MANIPULATOR (PSM) PART NUMBER 380900-02 AND SERIAL NUMBER (B)(4): ENGINEERING FOUND THAT THE PSM FAILED FRICTION TEST FOR AXIS-5. VISUAL INSPECTION FOUND THE ISSUE. THE LOWER LINK 4 PULLEY ASSEMBLY WAS DEFECTIVE. THE AXIS-5 PULLEY WAS SLIDING OFF THE BEARING AND WAS ALSO COCKED, WHICH ADDED UNWANTED FRICTION. THE PULLEY ASSEMBLY WAS REPLACED TO CORRECT THE PROBLEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR ARM FAILING THE SLOW SWEEP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND DURING PREVENTATIVE 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 (PM) OF THE DA VINCI SURGICAL SYSTEM BY THE INTUITIVE SURGICAL INC., REPRESENTATIVE OR FIELD SERVICE ENGINEER (FSE) IT WAS FOUND THAT THE PATIENT SIDE MANIPULATOR 1 (PSM) FAILED AXIS 5 FRICTION TEST AS WELL AS PSM 2 FAILED SLOW SWEEP. 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 PSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630532 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1