Events

Retiro De Equipo (Recall) de Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation 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 Brainlab 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-2013-RN-01273-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-29
  • 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-01273-1
  • 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, brainlab ag has determined that pins of the instrument star unit ml (calibration with icm4) with specific serial numbers might have been made using an incorrect material that is not suitable for necessary disinfection and sterilisation of the product. consequently, the biocompatibility of these specific products cannot be ensured. pins made of this incorrect material will not withstand the necessary reprocessing procedures described in the brainlab cleaning, disinfection and sterilisation guide. the prescribed reprocessing procedures will cause visible corrosion of pins made of this incorrect material. one or multiple pins of each product might be affected. if this corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient’s body, potentially leading to infection and serious injury of the patient.
  • Acción
    Customers are asked to identify the affected Instrument Star Units ML and remove them from clinical use. Brainlab Australia will arrange for affected stock to be recovered and replacement stock or a credit note to be issued.

Device

Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)
  • Modelo / Serial
    Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)Brainlab Article Number: 55830-25ASerial Numbers: 1205112016 and 1205112026ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd