BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM SILS PORT

    MDR report key: 2915804 · Received December 6, 2012

    Report

    Report Number
    1219930-2012-00972
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO THE REPORTER: TO ENTER THE BODY FLEXIBLE CLAMP DIRECTED SILS, THE SURGEON FEELS BREAKDOWN DEVICE AND PROCEED TO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL N0L0553K

    Patients

    Seq Age Sex Outcome Treatment
    1