BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM SILS PORT

    MDR report key: 2133816 · Received May 12, 2011

    Report

    Report Number
    1219930-2011-00394
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 20, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    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 TYPE: CHOLECYSTECTOMY. ACCORDING TO THE RPTR: NOTICED BEFORE THE CASE STARTED THAT THE TOP OF THE 5MM HAD COME OFF IN THE PACKAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1