BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 FIXATION CANNULA 5MM

    MDR report key: 1181999 · Received September 26, 2008

    Report

    Report Number
    2647580-2008-00563
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: THE CANNULA BROKE IN HALF IN THE CAVITY AFTER BEING INSERTED. SURGEON WAS ABLE TO REMOVE THE COMPLETE DEVICE. SURGEON INSERTED A NEW TROCAR TO CONTINUE ON WITH THE CASE. OR TIME DELAY WAS 10 MINUTES. NO BLEEDING OR PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 FIXATION CANNULA 5MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8G0035

    Patients

    Seq Age Sex Outcome Treatment
    1