Events

Rappel de Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments

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-2017-RN-00757-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • 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-2017-RN-00757-1
  • 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
    The manufacturer, olympus winter & ibe have identified specific item codes of sealing caps are missing information on the packaging that identifies the product as single-use and the sterility status of the sealing caps. these items are supplied unsterile and intended for single-use only following sterilisation. since there is no indication for single-use on the label it may be interpreted that the sealing cap can be reused. to date, olympus has not received any reports regarding adverse events or patient injury relating to this issue.
  • Action
    Olympus is advising users to inspect their inventory for the affected Sealing caps and discard. Olympus will provide corrected replacement stock.

Device

Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments
  • Modèle / numéro de série
    Sealing Caps (A0282 and A0313) used with compatible endoscopy instrumentsAll A0282 and A0313 batches affected, supplied with instruments and separately.Item numbers of A0282 compatible instruments: A22091A, A42091A, A4743, A4764, A4773Item numbers of A0282 compatible instruments: A4772, A4776, A37005AARTG Number: 188523
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd