BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BL VP V2 5MM STD W/FX

    MDR report key: 2843614 · Received October 24, 2012

    Report

    Report Number
    2647580-2012-00666
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 28, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K112349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TUBAL LIGATION. ACCORDING TO THE REPORTER: UPON PLACING THE TROCAR INTO THE PATIENT UNDER A 5MM LAPAROSCOPE VISUALIZATION, THE WHITE PLASTIC WASHER CONTAINED INSIDE OF THE CANNULA/SLEEVE RESPONSIBLE FOR MAINTAINING PNEUMO, WAS PUSHED OUT THROUGH THE TROCAR AND INTO THE CAVITY OF THE PATIENT. THE WASHER WAS THEN RETRIEVED AND ANOTHER TROCAR OPENED. THE TROCAR WAS REPLACED WITH ANOTHER 5MM VERSAPORT OPTICAL TROCAR AND USED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPT BL VP V2 5MM STD W/FX DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1