Events

Retiro De Equipo (Recall) de Disposable Reflective Marker Spheres

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-2015-RN-00768-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-27
  • 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-00768-1
  • 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
    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.
  • Acción
    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
  • Modelo / 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