BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 4035254 · Received August 25, 2014

    Report

    Report Number
    2955842-2014-05227
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND DOES NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STICKS OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .021 - .125 IN LENGTH AND 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 BROKEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE CABLE ON THE MEGA NEEDLE DRIVER INSTRUMENT SEPARATED. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512158 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10131213 106

    Patients

    Seq Age Sex Outcome Treatment
    1