Events

Rappel de 10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope

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-2018-RN-00841-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-02
  • 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-2018-RN-00841-1
  • 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 has updated section 7.9.1 gas sterilisation in the instructions for use for the wair100a and wair130a to include the following warning:“warningrisk of injury to the patient and usertoxic gasses can enter internal volumes of the product during gas sterilisation. the gasses can remain in the product and can leak out during use.· to remove toxic gasses, aerate the product sufficiently after sterilisation.”.
  • Action
    Olympus is requesting users: 1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control; 2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU; 3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and 5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.

Device

10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope
  • Modèle / numéro de série
    10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared TelescopeModel Number: WAIR100A10mm 30Deg Infrared TelescopeModel Number: WAIR130AAll Lot/Serial NumbersARTG Number: 146202(Olympus Australia Pty Ltd - Endoscope element, telescope)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd