Retiro De Equipo (Recall) de Talon Grasping Device(Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00354-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-27
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Us endoscopy has received a report of a grasping wire detachment during use and has determined the affected lot numbers. if wire detachment occurs, medical intervention may be required to prevent potential injury in the gastrointestinal tract.
  • Acción
    Users are advised to identify affected stock for returning it to Device Technologies.

Device

  • Modelo / Serial
    Talon Grasping Device(Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract)Product Code: U-711175Multiple lot numbers ARTG number: 168224
  • Manufacturer

Manufacturer