BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPORT V2 FIXATION CANNULA 5MM

    MDR report key: 2132226 · Received June 14, 2011

    Report

    Report Number
    2647580-2011-00392
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 26, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC HEPATECTOMY. ACCORDING TO THE REPORTER: THE TROCAR BROKE AS THE SURGEON PULLED IT OUT OF THE ABDOMEN. NO PIECES FELL INTO THE CAVITY, THE INCISION SIZE WAS NOT EXTENDED AND THERE WAS NO TISSUE DAMAGE. THE OPERATIVE TIME WAS EXTENDED OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 FIXATION CANNULA 5MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other