Events

Retiro De Equipo (Recall) de PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia 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-2015-RN-00422-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-18
  • 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-2015-RN-00422-1
  • 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
    During packaging verification testing, a breach in the sterile barrier was observed in some of the units tested. additional testing identified microscopic aluminium metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches in some of the units tested. it was determined that these particles were introduced during the manufacturing process and were sterilised within the tyvek pouch with the product. the potential hazards of this product issue include patient exposure to infectious material, potentially leading to patient infection, and patient exposure to sterile foreign material potentially leading to foreign body inflammation.
  • Acción
    Customers are asked to check any PenAdapt items in their possession and quarantine any affected units immediately. A Stryker Representative will contact customers to coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued to the customer account. Stryker is also requesting the customers to review the patient records for issues that may have been associated with the use of the affected device, such as infection and/or inflammation.

Device

PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or...
  • Modelo / Serial
    PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)Item number: 0702045027Multiple lot numbersARTG Number: 171568
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA