Events

Retiro De Equipo (Recall) de BiCision (electrosurgical thermofusion and dissection 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 Rymed 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-2013-RN-00186-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-28
  • 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-2013-RN-00186-1
  • 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
    Internal investigations found very few bicision instruments with the quality issue of low closing force of the jaw, which under unfavourable conditions could lead to insufficient thermofusion of large vessels or tissue bundles.This recall action was carried out prior to review by the tga.
  • Acción
    Rymed is advising users to remove all affected devices from use. Return all affected devices to Rymed for credit or replacement when available.

Device

BiCision (electrosurgical thermofusion and dissection system)
  • Modelo / Serial
    BiCision (electrosurgical thermofusion and dissection system)Lot / serial numbers: W3174973WO182954W3177733W3177734W3179128WN189444W3176581WN189947ARTG Number: 94173
  • Manufacturer
    Rymed Pty Ltd

Manufacturer

Rymed Pty Ltd