BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    MDR report key: 1082100 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00418
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 26, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAVH. ACCORDING TO THE REPORTER: A PLASTIC PIECE OF THE ANCHORING DEVICE FELL INTO THE PT ABDOMEN. THE SURGEON HAD PLACED THE TROCAR AND ACTIVATED THE ANCHORING DEVICE WHEN THIS OCCURRED AND THE SURGEON HAD TO REGRASP THE PLASTIC PIECE AND RETRIEVE IT THROUGH A SECOND PORT. ANOTHER DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ILL EFFECT TO THE PT, RECOVERED. THE SAMPLE IS BEING SENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIPORT 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8E0021

    Patients

    Seq Age Sex Outcome Treatment
    1