BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2233157 · Received September 2, 2011

    Report

    Report Number
    2955842-2011-00287
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE CARBIDE INSERT TO HAVE FALLEN OFF OF ONE OF THE GRIP TIPS. THE ENTIRE PIECE OF THE INSERT WAS DETACHED. THE GRIP TIP SURFACE WAS FOUND TO BE CLEAN WITH NO ADHESIVE RESIDUE. NO DAMAGE WAS FOUND TO THE INSTRUMENT'S CLEVIS OR CABLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHILE STARTING THE CUFF CLOSURE AND USING THE MEGA NEEDLE DRIVER INSTRUMENT, A PIECE OF THE INSTRUMENT JAW BROKE OFF AND FELL INTO THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED AND THE INSTRUMENT WAS REPLACED WITH ANOTHER INSTRUMENT OF THE SAME TYPE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, INJURY OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10110330 136

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES