BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HASSON

    MDR report key: 1850175 · Received September 14, 2010

    Report

    Report Number
    1850175
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ASCENT
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    A HASSON TROCAR IS SECURED TO THE INCISION SITE BY SUTURING. THERE ARE TWO "BUTTONS" ON EITHER SIDE. ONE OF THE BUTTONS FELL OFF OF THE TROCAR. IT WAS NOTED THAT A VERY SMALL PLASTIC FLANGE WAS BROKEN OFF. ALL PIECES WERE ACCOUNTED FOR AND THE ITEM WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HASSON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ASCENT H12LP 1172624

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR