BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3191662 · Received June 26, 2013

    Report

    Report Number
    2955842-2013-02314
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. ENGINEERING FOUND THAT THE SCISSORS WERE NOT DULL. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM FOR A LATEX CUT TEST AND THE SCISSORS CUT CLEANLY THROUGH .006 LATEX. THE BLADES WERE UNDAMAGED. ADDITIONAL DAMAGE ENGINEERING FOUND WAS MATERIAL REMOVAL FROM THE TUBE EXTENSION. ON ONE SIDE, THE TUBE EXTENSION EXHIBITED PAD-PRINTING REMOVAL, WHICH ALIGNED WITH THE TUBE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING THE DA VINCI SI SURGICAL MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOTED TO BE DULL. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291635 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10120816 800

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES