BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA

    MDR report key: 2359261 · Received November 23, 2011

    Report

    Report Number
    2359261
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 23, 2011
    Manufacturer
    SOUTHMEDIC INC
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS MAKING A STABBING INCISION PORTS THROUGH THE KNEE JOINT UNDER THE GUIDANCE OF THE ARTHROSCOPE AND VIDEO SYSTEM. SURGEON USED A #11 KNIFE BLADE TO MAKE INCISIONS TO ENTER THE KNEE JOINT TO MAKE AN OPENING FOR A KNEE INSTRUMENT TO USE IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERSONA #11 BLADE GES SOUTHMEDIC INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *