Events

Retiro De Equipo (Recall) de Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-2017-RN-00584-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-09
  • 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-2017-RN-00584-1
  • 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
    Cook medical have identified that the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of specific endoscopic curved needle driver, lapsac introducer and lapsac introducer set products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. to date, the manufacturer has received no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include localised surgical site infection, to deeper organ space infection, as well as chemical residual exposure.
  • Acción
    Cook Medical is advising users to examine their inventory immediately to identify and quarantine any affected products. Products are to be discarded or returned to Cook Medical.

Device

Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer Set
  • Modelo / Serial
    Endoscopic Curved Needle Driver, LapSac Introducer and LapSac Introducer SetEndoscopic Curved Needle DriverCatalogue Numbers: 096511, J-ENH-033100, J-ENH-053100, J-ENH-053120 and J-ENH-053130ARTG Number: 212233LapSac IntroducerCatalogue Number: J-LSI-102500ARTG Number: 276893LapSac Introducer SetCatalogue Number: 054300Previous ARTG Number: 276893All Lots
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd