Events

Retiro De Equipo (Recall) de Covidien Devon Light Glove

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-2017-RN-00008-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-05
  • 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-00008-1
  • 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 occasions, the devon light glove may split upon application to the devon light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. there have been two reports in which splits were found at the conclusion of surgery.
  • Acción
    Medtronic is advising the distributor to quarantine and discontinue use of the affected lots prior to returning them for a credit. The distributor is further requested to forward the recall letter to hospitals with the affected lots.

Device

Covidien Devon Light Glove
  • Modelo / Serial
    Covidien Devon Light Glove Product Codes: 571711, 31140208, 31140216, 31140257All Lot Numbers within expiry beginning with 630XXXXXXX and lower ARTG 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