BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM SILS PORT

    MDR report key: 2133282 · Received May 11, 2011

    Report

    Report Number
    1219930-2011-00386
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 17, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K082619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, A FOREIGN MATERIAL FELL INTO THE PT'S CAVITY AND IT WAS RETRIEVED. IT LOOKED LIKE A PIECE OF 5MM SLEEVE. THE RETICULATED TIP PART OF THE DEVICE HAD BURR. NO BLEEDING. NO TISSUE DAMAGED. OPERATING ROOM TIME NOT EXTENDED MORE THAN 30 MINS. NO PT INFO AVAILABLE. 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 N0M191K

    Patients

    Seq Age Sex Outcome Treatment
    1