BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACOPORT 10.5MM TROCAR

    MDR report key: 2932370 · Received January 7, 2013

    Report

    Report Number
    2647580-2013-00014
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K992288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LUNG BIOPSY. ACCORDING TO THE REPORTER: A PIECE OF THE THORACOPORT BROKE OFF IN THE PATIENT'S CHEST. NO HARM TO THE PATIENT. THE PIECE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8472 THORACOPORT 10.5MM TROCAR DISPOSABLE ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC P2F0307X

    Patients

    Seq Age Sex Outcome Treatment
    1