Events

Recall of 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)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Varian Medical Systems Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00446-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00446-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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