BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 1181994 · Received September 26, 2008

    Report

    Report Number
    2647580-2008-00559
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE STRUCTURAL BALLOON WAS USED AS NORMAL, HOWEVER, THE GREY SEAL ON THE CANNULA CAME LOOSE TOWARDS END OF CASE WHEN LAPAROSCOPE PLACED IN AND DROPPED INTO THE PT. THE SEAL WAS RECOVERED WITH NEW PRODUCT, THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. THE OPERATING TIME AND INCISION WERE NOT EXTENDED, AND THERE WAS NO BLOOD LOSS. NO PT INJURY WAS REPORTED. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER STRUCTURAL BALLOON TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8F0880

    Patients

    Seq Age Sex Outcome Treatment
    1