Events

Retiro De Equipo (Recall) de GastriSail Gastric Positioning System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-01227-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-27
  • 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-2017-RN-01227-1
  • 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
    Medtronic is recalling specific production lots of its gastrisail gastric positioning system device. this recall is being conducted following customer reports of oesophageal or gastric perforations during bariatric procedures where the gastrisai gastric positioning system was used. eighteen reports, representing 0.08% of devices, were received regarding this issue; many of these perforations were identified post-operatively. according to complaints, the part of the device causing perforation may be the distal tip during device insertion or when meeting resistance as it is advanced. some complaints also referenced tissue trauma or perforation thought to be caused by inability to fully retract the sail, leading to kinking of the sail and risk to tissue.
  • Acción
    Medtronic requests that users quarantine and return any unused products of the items. All unused products from the affected item code and lots should be returned to Medtronic.

Device

GastriSail Gastric Positioning System
  • Modelo / Serial
    GastriSail Gastric Positioning SystemItem Code: GPS36All Lot NumbersExpiry date: September 2017 to May 2018ARTG Number: 246455
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA