Events

Retiro De Equipo (Recall) de Symmetry Surgical/Olsen – Single Use Electrocautery Forceps/Pencils/Cords

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-2018-RN-00795-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00795-1
  • 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
    Device technologies has been notified by the manufacturer, symmetry surgical, of a product complaint regarding a monopolar pencil and cord. the reporting site observed some anomalies in the packaging seal resulting from the package’s contents having migrated near or within the seal area. this condition increases the risk of the seal’s integrity being compromised. testing indicated that the defect is introduced during the packaging operation and will not result from shipping or normal handling conditions.
  • Acción
    Device Technologies (DTA) is advising customers product is acceptable for use if it is visually confirmed that the package's contents do not interfere with the packaging seal and the seal is intact. Users are advised to either: - Inspect all affected product in accordance with the inspection instructions outlined in the Customer Letter. Product that does not meet acceptance criteria should be shipped back to DTA for credit. If users are uncertain if product is acceptable it is advised to return the item; OR - Ship stock held of the Olsen Single Use Electrocautery Forceps/Pencils/Cords back to DTA for credit.

Device

Symmetry Surgical/Olsen – Single Use Electrocautery Forceps/Pencils/Cords

Manufacturer

Device Technologies Australia Pty Ltd