Events

Retiro De Equipo (Recall) de Surface Applicator Set with Leipzig-style Cone(indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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-00446-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-27
  • 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-00446-1
  • 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 dosimetry data provided in the leipzig-style surface applicator's ifu was derived by performing monte carlo simulations. subsequent simulations were performed to refine the data, but this refined data was not published in an ifu update. the most significant discrepancy is that the actual dose rate of the applicator is approximately 14% higher than the rate published within the ifu. use of the dose rate as provided by the ifu without independent confirmation of the dose could result in an administration of dose greater than intended. this failure mode is not easily recognised by the user.
  • Acción
    Users are recommended the following action: · Users should CEASE USE of the published dose rate in the Surface Applicator Set with Leipzig-style Cone, GM11010080 IFU: Dose Characterization GM11010080 2012-09-06 · Users may use the Acuros BV to calculate dose rates and dose distributions of the surface applicators. · Users may use Thermoluminescent Dosimeters (TLDs) to obtain dose rates & dose distributions of the surface applicators. · Users may measure the surface applicator dosimetry using methods recommended in the following publication: Fulkerson RK, Micka JA, DeWerd LA. Dosimetric characterization and output verification for conical brachytherapy surface applicators. Part II. High dose rate 192lr sources. Medical Physics. 2014;41(2):022104. doi: 10.1118/ 1.4862506. Varian is continuing its investigation and will update the IFU with corrected values as soon as possible. Varian will distribute updated Leipzig-style Surface Applicator's IFU to all affected users upon release. This action has been closed-out on 17/08/2016.

Device

Surface Applicator Set with Leipzig-style Cone(indicated for treatment of small skin tumours or o...
  • Modelo / Serial
    Surface Applicator Set with Leipzig-style Cone(indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy)IFU version: Dose Characterization GM11010080, 2012-09-06 ARTG Number: 126867
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd