BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STEP DEVICE

    MDR report key: 1210036 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00603
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    PONCE- USS
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: A PLASTIC RING FELL OFF ONE OF THE STEP TROCAR AND INTO THE PT. THE SURGEON WAS ABLE TO RETRIEVE IT. THE PT IS FINE AT THIS POINT. SURGEON REMOVED THE PLASTIC RING FROM INSIDE THE PT. PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STEP DEVICE DISPOSABLE SURGICAL ACCESS DEVICE GDW PONCE- USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1