Disposable Reflective Marker Spheres 의 리콜

Recall

RC-2015-RN-00768-1

Class II

2015-08-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00768-1

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.

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.