Events

Retiro De Equipo (Recall) de E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Big Green Surgical Company 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-00854-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-12
  • 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-00854-1
  • 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 distal portion of the electrode insulation of a small number of units may have been damaged during manufacture. in the event that a unit with damaged insulation is used on a patient contrary to recommended instructions for use supplied with the product, thermal damage could occur to the patient’s peripheral tissue. such damage would be outside the surgeon’s primary field of view during a laparoscopic procedure and therefore not easily identified at the time of occurrence. .
  • Acción
    Big Green Surgical is requesting users to quarantine all affected units. Affected stock will be replaced by Big Green Surgical or a credit note issued.

Device

E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)

Manufacturer

Big Green Surgical Company Pty Ltd