BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3953867 · Received July 23, 2014

    Report

    Report Number
    2955842-2014-04505
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT OF SMALL FRAGMENT NOTED ON SIDE WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT BIPOLAR YAW PULLEY WAS BROKEN. THERE WAS A SMALL PIECE CHIPPED OFF THE BIPOLAR YAW PULLEY MEASURING 0.018 X 0.012. THE CHIPPED DAMAGE MAY BE CAUSED BY FORCEFUL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. FAILURE ANALYSIS CONCLUDED THE BROKEN DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS -HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE SMALL PIECE CHIPPED OF BIPOLAR YAW PULLEY WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI TRANSORAL SURGERY THE PERMANENT CAUTERY SPATULA INSTRUMENT COULD NOT BE RETRACTED FROM PORT. A SMALL FRAGMENT WAS NOTED TO BE MISSING FROM THE INSTRUMENT AND WAS RETURNED WITH THE INSTRUMENT. THERE WERE NO FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432009 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10130822 820

    Patients

    Seq Age Sex Outcome Treatment
    1