BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM SILS PORT

    MDR report key: 1993599 · Received January 24, 2011

    Report

    Report Number
    1219930-2011-00047
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: WHEN INSERTING THE DEVICE, A PIECE OF THE CANNULA SEAL BROKE OFF AND FELL INTO THE PT CAVITY CAUSING THE SEAL TO LEAK AIR. THE PIECE WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. THERE WAS NO ADDITIONAL BLEEDING, NO TISSUE DAMAGE, NO INCISION EXTENSION AND OPERATIVE TIME WAS NOT INCREASED BY MORE THAN 30 MINS. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL N0G0159

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR