Events

Retiro De Equipo (Recall) de Covidien Endo GIA Articulating Reloads with Tri-Staple Technology

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-2018-RN-00655-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-06-06
  • 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-2018-RN-00655-1
  • 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 has identified the potential for the device to have a misassembled (reversed) sled component. the sled component is responsible for staple deployment. when the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. this may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery. internationally, medtronic have received one report of injury related to this issue. to date, there have been no reported injuries in australia.
  • Acción
    Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.

Device

Covidien Endo GIA Articulating Reloads with Tri-Staple Technology
  • Modelo / Serial
    Covidien Endo GIA Articulating Reloads with Tri-Staple TechnologyEndo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology Item Code: EGIA45AMT Lot: N7L0521KXARTG:181429 Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple TechnologyItem Code: EGIA45AXT Lots: N8A0907KX and N8A0146KX ARTG:181429Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple TechnologyItem Code: EGIA60AVM Lot: N8B0088KX ARTG:186247
  • Clasificación del producto
    General and Plastic Surgery Devices
  • 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