Events

Rappel de MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00991-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00991-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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