BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS

    MDR report key: 1111028 · Received August 12, 2008

    Report

    Report Number
    2647580-2008-00463
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 17, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 08/12/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC ENDOMETRIOSIS. ACCORDING TO THE REPORTER: SMALL SHAVINGS OF PLASTIC APPEARED IN THE ABDOMINAL WALL AS THE PORT WAS INSERTED INTO ABDOMEN. THE SURGEON NEEDED TO MAKE ANOTHER INCISION INTO THE ABDOMEN TO RETRIEVE THE SMALL SHAVINGS. NO PT INJURY WAS REPORTED. NO ADD'L INFO WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8E0198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R