Events

Retiro De Equipo (Recall) de Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus 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-00757-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-27
  • 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-00757-1
  • 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
    The manufacturer, olympus winter & ibe have identified specific item codes of sealing caps are missing information on the packaging that identifies the product as single-use and the sterility status of the sealing caps. these items are supplied unsterile and intended for single-use only following sterilisation. since there is no indication for single-use on the label it may be interpreted that the sealing cap can be reused. to date, olympus has not received any reports regarding adverse events or patient injury relating to this issue.
  • Acción
    Olympus is advising users to inspect their inventory for the affected Sealing caps and discard. Olympus will provide corrected replacement stock.

Device

Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments
  • Modelo / Serial
    Sealing Caps (A0282 and A0313) used with compatible endoscopy instrumentsAll A0282 and A0313 batches affected, supplied with instruments and separately.Item numbers of A0282 compatible instruments: A22091A, A42091A, A4743, A4764, A4773Item numbers of A0282 compatible instruments: A4772, A4776, A37005AARTG Number: 188523
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd