BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM SILS PORT

    MDR report key: 1853947 · Received September 29, 2010

    Report

    Report Number
    2647580-2010-00796
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 31, 2010
    Manufacturer
    USSC PUERTO RICO
    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: LAVH. ACCORDING TO THE REPORTER: DURING THE CASE, THE SEAL FROM ONE OF THE CANNULAS CAME OFF AND FELL INTO THE PT CAVITY. THE PIECE WAS RETRIEVED. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADD'L BLEEDING AND NO TISSUE DAMAGED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED. NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1