Events

Retiro De Equipo (Recall) de Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm

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-00261-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-20
  • 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-00261-1
  • 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
    This recall is being conducted due to the potential for the sterile packaging to be compromised, as a result of holes in the sterile packaging. the use of products with this condition may result in a potentially increased risk for infection. there have been no reports of infection associated with this issue.
  • Acción
    Medtronic is advising users to inspect stock and quarantine any remaining units of the affected batches. Affected stock can be returned to Medtronic for credit.

Device

Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm
  • Modelo / Serial
    Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm Item Code: LF2019Lot Numbers:72550127X, 72770140X, 72770141X, 73000048XShipped between November 2017 and February 2018ARTG number: 178655(Medtronic Australasia - Electrode, electrosurgical, active, hand-controlled, single use)
  • 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