BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3973758 · Received August 1, 2014

    Report

    Report Number
    2955842-2014-04664
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 3, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE GRIP CABLE IS FRAYED AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT STICKS OUT AT THE WRIST. THE DISTAL CLEVIS HUB DOES NOT EXHIBIT ANY WEAR. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE FRAYED GRIP CABLE, AND THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN RETURNED FOR EVALUATION, HOWEVER; FAILURE ANALYSIS INVESTIGATION OF THE RETURNED AFFECTED PART IS NOT COMPLETE. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE EXPOSED WIRES 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 DURING A DA VINCI SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WIRES ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WERE SHOWING. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO THE PATIENT AND THERE WAS NO ALLEGATION OF PATIENT HARM OR ADVERSE OUTCOME INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450241 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140320 734

    Patients

    Seq Age Sex Outcome Treatment
    1