BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEDDLE DRIVER INSTRUMENT

    MDR report key: 2962581 · Received February 14, 2013

    Report

    Report Number
    2955842-2013-00514
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K990144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY WAS ABLE TO SPIN FREELY AND IT DID NOT EXHIBIT ANY DAMAGE. THE CABLE SEGMENT STUCK OUT AT WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI HYSTERECTOMY PROCEDURE, ITEM BROKE AT THE TIP OF THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT (WIRES FRAYED). NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64894 MEGASUTURECUT NEDDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400309-01 M10111118 027

    Patients

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