Events

Recall of Disposable Reflective Marker Spheres

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia 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-00768-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00768-1
  • 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
    Some drms spheres may separate at the mid-point where the two halves of the sphere are sealed together. separation may occur during installation of the spheres onto reference arrays or surgical tools (i.E., when threading them onto posts), or potentially after installation on tools that are impacted with high forces. should such a drms separate during a surgical procedure, there is a possibility for:- a portion of the sphere, its reflective coating and cured or uncured adhesive contacting patient tissues. - contamination of surgical trays, surgical drapes, surgical tools or physicians’ gloves due to contact with the separated component. - prolongation of surgery due to the need to replace the broken sphere. the resulting separated sphere halves will not continue to be tracked by the brainlab image guided surgery system. the failure rate for the affected lots is less than 0.5% and there have been no reported negative effects on any patient associated with this issue.
  • Action
    Brainlab is providing workaround instructions to assist healthcare professionals in determining if the spheres are defective. Unaffected alternative product is not available at this stage. This action has been closed-out on 25/08/2016.

Device

Disposable Reflective Marker Spheres
  • Model / Serial
    Disposable Reflective Marker SpheresProduct Numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs)41774G Disposable Reflective Marker Sphere (270 Pcs)41772G Disposable Reflective Marker Sphere (3 Pcs)Lot Numbers: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd