BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM SILS PORT

    MDR report key: 2112934 · Received May 25, 2011

    Report

    Report Number
    1219930-2011-00446
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING PREPARATION FOR SURGERY, IT WAS FOUND THAT THE PLASTIC PART ON THE DEVICE WAS PARTIALLY CHIPPED. THE DEVICE WAS NOT USED FOR THE PT. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL N0H0297

    Patients

    Seq Age Sex Outcome Treatment
    1