BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3971222 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04641
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    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 FAILURE MODE AS THE INSTRUMENT'S CABLE IS NOT BROKEN, FRAYED, LOOSE OR DAMAGED AT THE TIP, FRAYED, LOOSE, OR FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE INSTRUMENT'S MAIN TUBE IS CRACKED APPROXIMATELY 5.33 FROM THE DISTAL END. IT WAS CONCLUDED THAT THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE ADDITIONAL FINDING OF THE CRACK IN THE MAIN TUBE FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE ON THE LARGE NEEDLE DRIVER INSTRUMENT WAS BROKEN. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT AND THERE WAS NO ALLEGATION OF PATIENT HARM OR ADVERSE OUTCOME OCCURRED INVOLVING THE REPORTED INSTRUMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446543 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10110809 736

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES