Events

Retiro De Equipo (Recall) de Devon Light Glove (Used as a cover with a compatible surgical light handle)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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-01291-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-06
  • 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-2016-RN-01291-1
  • 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
    Customers have reported that on rare occasion (complaint rate less than 2/100,000 or 0.0017%), the devon light glove may split upon application to the devon light handle adapter. a subset of these splits reportedly resulted from a difficult application of the glove to the handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. there have been no reports of serious injury associated with these rarely occurring splits.
  • Acción
    Medtronic is adding the statement "After application, inspect the Light Glove for barrier integrity" to the Devon Light Glove Instructions for Use (IFU) and notifying this information to the users through the customer letter.

Device

Devon Light Glove (Used as a cover with a compatible surgical light handle)
  • Modelo / Serial
    Devon Light Glove (Used as a cover with a compatible surgical light handle)3611 Flexbl Lite Glove 1ea/pkgProduct Code: 311402083613 Lite GLV-Flexible 3ea/pkgProduct Code: 311402163612 Lite GLV-Flexible 2ea/pkgProduct Code: 31140257ARTG Number: 186761
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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