Events

Retiro De Equipo (Recall) de Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite 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 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-00142-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-31
  • 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-00142-1
  • 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
    A problem has identified a problem with the diego elite tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. if the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. at this stage, no reports of injuries relating to the drive shaft disengagement have been received.
  • Acción
    Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or replacement stock.

Device

Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and sucti...
  • Modelo / Serial
    Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)Item Codes: TS100S and TS101DCMultiple Lot Numbers ARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd