Events

Retiro De Equipo (Recall) de Auriga XL 4007 Laser 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 Boston Scientific 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-01215-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-21
  • 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-01215-2
  • 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
    Boston scientific has identified certain auriga xl 4007 laser system consoles which may have an incorrectly assembled trigger wire. the trigger wire functions in the start-up of the console. an incorrectly assembled trigger wire may result in error codes or failure to start the console. should the console fail to start, the most common consequence would be a delay of the procedure while the affected console is swapped for another. if a substitute console or immediate alternative treatment is not available, this issue may result in moderate risk to the patient related to repeat anaesthesia for the re-intervention at a later date.
  • Acción
    1. Users are to stop using the affected goods and complete and return the supplied correction form to indicate receipt of the letter. 2. Boston Scientific certified engineers will begin contacting customers to schedule correction of affected consoles within two weeks of this communication.

Device

Auriga XL 4007 Laser System
  • Modelo / Serial
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M0068FS4007G0 Serial Numbers: 20546219 and 20575518 ARTG Number: 287772
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA