BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPT BL VP V2 5MM STD W/FX

    MDR report key: 3082880 · Received April 22, 2013

    Report

    Report Number
    1219930-2013-00280
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K112349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAVH. ACCORDING TO THE REPORTER: WHILE USING THE 5MM OPTICAL TROCAR THE GAS SEAL FELL INTO THE ABDOMINAL CAVITY. THEY WERE ABLE TO RETRIEVE THE SEAL AND THE PT IS DOING FINE. POST-OPERATIVE INFECTION DEVELOPED. NO CAUSE FOR THE INFECTION HAS BEEN DETERMINED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172987 OPT BL VP V2 5MM STD W/FX DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL N3B0173X

    Patients

    Seq Age Sex Outcome Treatment
    1