BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2072729 · Received April 29, 2011

    Report

    Report Number
    2955842-2011-00126
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WITH THE SITE HAVE BEEN MADE, HOWEVER, AT THE TIME OF THIS REPORT, THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS SUTURING AND USING THE MEGA NEEDLE DRIVER INSTRUMENT, A BREAK OCCURRED IN THE INSTRUMENT SHAFT AND 'PLASTIC' FRAGMENTS FELL INTO THE PATIENT'S ABDOMEN. ONE PIECE WAS RETRIEVED, HOWEVER, TINY FRAGMENTS WERE UNABLE TO BE REMOVED AND REMAIN IN THE PATIENT. THE INSTRUMENT WAS REPLACED WITH ANOTHER INSTRUMENT OF THE SAME TYPE AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-07 S10081114 412

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES