Events

Retiro De Equipo (Recall) de Karl Storz Tissue Morcellation 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 Karl Storz Endoscopy 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-2015-RN-00310-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-14
  • 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-2015-RN-00310-1
  • 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
    Karl stoz is undertaking update of the karl storz tissue morcellation system instructions for use (ifu) by adding new ‘contraindications’ and ‘warnings’ .In 2014, the united states food and drug administration issued it’s ‘immediately in effect guidance document: product labelling for laparoscopic power morcellators’. karl storz submitted a morcellator labelling change request and after receiving the fda’s approval have now implemented the changes. the update to the ifu is in line with the the tga’s safety advisory about the laparoscopic power morcellators on august 4, 2014 which is available at https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014 .
  • Acción
    Karl Storz is informing the customers of the new ‘Contraindications’ and ‘Warnings’ in the IFU and providing them with a link to the new IFU. This action has been closed-out on 9/08/2016.

Device

Karl Storz Tissue Morcellation System

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd