Events

Retiro De Equipo (Recall) de Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-00964-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-20
  • 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-2016-RN-00964-1
  • 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
    The adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the electric pen drive (epd) system to operate the colibri and colibri ii with the epd consoles. the adaptor can be inserted into the colibri or colibri ii handpiece and removed like a battery pack.There is a potential for the adapter for colibri and adapter for colibri ii to generate excessive internal pressure that may cause the respective products to burst. preliminary tests for this failure mode by the manufacturer have determined this scenario is highly unlikely to occur. there have been no injuries as a result of this issue.
  • Acción
    JJM is advising users to inspect stock and quarantine any units of the affected adapters. The Colibri Drill system is able to be operated by the use of specific batteries; listed below. These products will be made available. • Universal battery charger, Product 05.001.204 • Battery case, Product 532.132 • 14.4V Lithium-Ion battery Product 532.103 • Sterile transfer product 532.104

Device

Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece
  • Modelo / Serial
    Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand pieceAdapter for Colibri, Electric Pen DriveProduct Number: 05.001.024Light Adapter for Colibri and Colibri II hand pieceProduct Number: 05.001.108All lots affectedARTG Number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes