BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 FIXATION CANNULA 5MM

    MDR report key: 1210034 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00601
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 9, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE CANNULA SNAPPED IN HALF WHILE A GRASPER WAS INSIDE IT. THE HUB WAS RETRIEVED FROM THE CAVITY AS WELL AS THE BROKEN PIECE. A NEW DEVICE WAS OPENED FOR THE COMPLETION OF THE CASE. OR TIME WAS DELAYED APPROXIMATELY 20 MINS. NO BLEEDING OR INJURY REPORTED. NO PT INJURY WAS 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 P8G0790

    Patients

    Seq Age Sex Outcome Treatment
    1