Events

Retiro De Equipo (Recall) de MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus 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-00991-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-07
  • 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-00991-1
  • 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
    Small puncture marks that are not easily visible by eye have been found on the packaging of the maj-1606. this damage was caused by variations in the packaging process.A sample of devices with these small puncture marks was sent by the manufacturer for bio-burden testing. this testing concluded that no bacterial contamination was detected from any of the adaptors sampled.Both the manufacturer and olympus have not received any complaints of injury associated with compromised sterile packaging, however, as a precaution olympus is recalling the two affected lot numbers.
  • Acción
    Customers are asked to immediately cease use of any affected product they have and to quarantine affected units until they can be returned to Olympus as per the instructions in the Customer Letter. A credit or replacement will then be issued free of charge for any returned product. This action has been closed-out on 05/09/2016.

Device

MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water ...
  • Modelo / Serial
    MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube)Item Codes: K10016091 – MAJ-1606Lot Numbers: 20115441 and 20116536 ARTG Number: 222646
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd