Retiro De Equipo (Recall) de VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. in addition, the monitoring of chemical residues was not considered in the reprocessing validation. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidelines. potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. to date, there have been no reports of adverse reactions related to inadequate cleaning, disinfection, sterilisation or chemical residual exposure associated with these devices.(please note that for the endoscopic system, the reprocessing instructions apply to the vueoptic visualisation source as the flexor 180 is intended for one-time use only).
  • Acción
    Cook Medical will be updating the reprocessing instructions in the Instructions For Use (IFU). In the interim, users are advised to quarantine any affected products. Use of the affected products can be continued if the updated "Reprocessing Instructions" provided is adhered to. (Users are to note that the reprocessing instructions apply to the VueOptic Visualisation Source as the Flexor 180 is intended for one-time use only).


  • Modelo / Serial
    VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic SystemVueOptic Visualisation Source Catalogue Identifier: FVO-150Part Number: G25343Flexor Vue Deflecting Endoscopic System Catalogue Identifiers: FV-090075-150 & FV-090045-150Part Numbers: G50972 & G34306 (respectively)All Lot NumbersARTG Numbers: 211575 and 211572
  • Manufacturer