Events

Retiro De Equipo (Recall) de PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Given Imaging Pty Limited.

¿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-2012-RN-01008-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-28
  • 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-2012-RN-01008-1
  • 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
    Given imaging has received reports of failures of the pillcam during normal use and when the product was used in a manner that was not supported by its design specifications and tolerance's.
  • Acción
    Given Imaging is recalling all affected devices and ceasing supply. There are alternative products available for customers.

Device

PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB vid...
  • Modelo / Serial
    PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time)Part Numbers: FGS-0366 & FGS-0367Batch Numbers: 15720 to 18568Supplied between August 2010 and July 2012ARTG Number: 174813
  • Manufacturer
    Given Imaging Pty Limited

Manufacturer

Given Imaging Pty Limited
  • 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