BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3981844 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04732
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 7, 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. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT INSTALLED ON AN IN-HOUSE IS3000 SYSTEM PASSED RECOGNITION/ENGAGEMENT TESTING WITH NO ISSUES NOTED. AN IN-HOUSE TEST SUTURE WAS GRASPED AND DRIVEN THROUGH RED FOAM WITH NO ISSUES. THE INSTRUMENT ALSO GRIPPED WITH NO ISSUES. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE GRIP ISSUE EXPERIENCED BY THE SURGEON 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 WITH SACROCOLPOPEXY PROCEDURE, IT WAS NOTED THAT ONE OF JAWS ON THE LARGE NEEDLE DRIVER INSTRUMENT WAS NOT HOLDING THE SUTURE. 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
    458557 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10140415 361

    Patients

    Seq Age Sex Outcome Treatment
    1