Events

Retiro De Equipo (Recall) de Mako Internal cPCI Card Cage

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2017-RN-00857-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-11
  • 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-2017-RN-00857-1
  • 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
    Stryker has determined that during assembly of the cpci card cage, a potential cross threading of the 3.3 vdc lug may exist. visual inspection did not confirm the assembly error. this condition could result in an intermittent power connection in the cpci card cage and abnormal system behaviour or a total loss of power. powering down of the system due to intermittent or total loss of power is estimated to have a probability of occurrence at 0.0022%. this would make the system temporarily unavailable. potential harms resulting in this failure mode are extended surgical time of =15 minutes or extended surgical time of >30 minutes.
  • Acción
    Stryker is requesting customers: 1. Inform users of this Recall for Product Correction and forward the notice supplied to all internal staff who need to be aware of this issue; 2. A Stryker representative will coordinate a time for the inspection and, if necessary, replace the cPCI Unit. The Mako may continue to be used in the meantime; 3. Complete the supplied “Recall for Product Correction Notification Response” form to acknowledge you have seen this letter. Return the completed form to Stryker by email to recalls@stryker.com or fax on (02) 9467 1325; and 4. If affected stock could have been transferred from your hospital to another location, please immediately let them know of this recall action.

Device

Mako Internal cPCI Card Cage
  • Modelo / Serial
    Mako Internal cPCI Card CageItem Number: 201337Lot Number: 05212015ARTG Number: 223105
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA