Events

Retiro De Equipo (Recall) de Brainlab Disposable Reflective Marker Spheres (DRMS)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Northern Digital Inc.

¿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
    19094
  • Fecha de inicio del evento
    2015-11-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Causa
    Some drms 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.
  • Acción
    Product to be returned to supplier

Device

Brainlab Disposable Reflective Marker Spheres (DRMS)
  • Modelo / Serial
    Model: 41773G, 41774G, 41772G, Affected: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401
  • Manufacturer
    Northern Digital Inc

Manufacturer

Northern Digital Inc