Events

Retiro De Equipo (Recall) de PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)

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-2016-RN-00392-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-04
  • 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-2016-RN-00392-1
  • 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
    An issue has been identified that when the affected device is operating with a flow setting of 18l/min or greater and connected to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red “check gas supply” symbol would appear on the display, immediately suspending insufflation.The failure produced by the defective product is the red “check gas supply” error on the display that occurs when the insufflator has a flow setting of 18l/min or greater. during a procedure, this would result in pressure decrease in the abdomen. unclear image due to poor abdominal distention is the hazardous situation associated with low gas pressure during a procedure.
  • Acción
    Stryker is advising users to inspect stocks and quarantine any affected units. A Stryker representative will contact the affected customers to arrange for the removal and replacement of the affected units. This action has been closed-out on 02/02/2017.

Device

PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnosti...
  • Modelo / Serial
    PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)Catalogue Numbers: 0620040610, 0620040611, 0620040600Multiple Lot Numbers affectedARTG Number: 139712
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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