Events

Retiro De Equipo (Recall) de Base array component of the MAKO RIO Robotic Arm

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-2015-RN-00873-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-08
  • 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-00873-1
  • 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
    The base array and the base array connector is a two piece component on the rio that is used by the rio camera to determine location of the rio relative to the patient. the pin which olds the base array in position and prevents movement has been visually confirmed to have been damaged during assembly.Incidences have been reported where the locking pin on the rio base array may be damaged during assembly onto the rio base array connector.The incidence of this issue is uncommon (only 0.15% of cases over the past 36 months) and, of the reported cases, all were successfully completed with no reported injury to the patient or operating room staff.
  • Acción
    Users are requested to complete and return the notification response. A Stryker Representative will be in contact and a new RIO Base Array Connector and Base Array will be installed on the RIO system during regularly scheduled product maintenance. A workaround is also provided for interim use of the system.

Device

Base array component of the MAKO RIO Robotic Arm
  • Modelo / Serial
    Base array component of the MAKO RIO Robotic ArmCatalogue Numbers:207300 (207956) MAKO RIO Robotic Arm112220 RIO Base Array205143 RIO Base Array ConnectorLot/Serial Numbers: AllARTG Number: 223105
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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