BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BL VP V2 5MM STD W/FX

    MDR report key: 3102050 · Received April 22, 2013

    Report

    Report Number
    1219930-2013-00282
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K112349
    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: HYSTERECTOMY. ACCORDING TO THE REPORTER: WHILE USING THE 5MM OPTICAL TROCAR, THE GAS SEAL FELL INTO THE ABDOMINAL CAVITY IN A ROBOTICALLY ASSISTED TOTAL HYSTERECTOMY. THEY WERE ABLE TO RETRIEVE THE SEAL AND THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172015 OPT BL VP V2 5MM STD W/FX DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN LP, FORMERLY US SURGICAL N3AO482X

    Patients

    Seq Age Sex Outcome Treatment
    1