BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACOPORT 11.5MM TROCAR

    MDR report key: 2062609 · Received April 8, 2011

    Report

    Report Number
    2647580-2011-00236
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 14, 2011
    Manufacturer
    USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K992288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VATS LOBECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE CANNULA WAS DAMAGED. THE BROKEN PIECES WERE RETRIEVED, BUT SOME MIGHT HAVE REMAINED IN THE CAVITY. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO PATIENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACOPORT 11.5MM TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO, INC. P0J0412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other