BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 FIXATION CANNULA 12MM

    MDR report key: 2822061 · Received October 9, 2012

    Report

    Report Number
    2647580-2012-00646
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ACCORDING TO THE REPORTER: THE TROCAR BROKE AND THE UPPER PART FROM LOWER PART WERE SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 FIXATION CANNULA 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC P1J0561

    Patients

    Seq Age Sex Outcome Treatment
    1