BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM SILS PORT

    MDR report key: 1853951 · Received September 29, 2010

    Report

    Report Number
    1219930-2010-00762
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    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: LAP CHOLE. ACCORDING TO THE REPORTER: DURING THE CASE, THE SEAL (RUBBER PART OF THE CANNULA) DISENGAGED. THE PIECE WAS RETRIEVED. THERE WAS NO ADD'L BLEEDING AND NO TISSUE DAMAGE. THE OPERATING TIME WAS NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED. NO ADD'L PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM SILS PORT NONE GCJ UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1