Events

Retiro De Equipo (Recall) de Monopolar HF Resection Electrodes

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-00498-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-20
  • 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-00498-1
  • 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 has received an increased number of complaints regarding loop wires breaking at the distal end of the electrodes. investigations have confirmed that loop wires can break during the intended use of the electrodes. as a result, a fragment may fall inside the patient and will need to be retrieved. under certain circumstances, the retrieval could require additional surgical treatment. to date, no reports of adverse events or patient injuries have been received by olympus.
  • Acción
    Olympus is requesting users to inspect their inventory and quarantine the affected lots. Affected products are to be returned for replacement.

Device

Monopolar HF Resection Electrodes
  • Modelo / Serial
    Monopolar HF Resection ElectrodesModel Number: A22201CLot Numbers: 16123P03L001, 16139P03L001, 16144P03L001, 16173P03L001, 16174P03L001, 16210P03L001, P16X0001, P16X0002, P16Y0001 and P16Y0003Model Number: WA22037CLot Number: P16Y0001ARTG Number: 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd