Events

Recall of 10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00841-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00841-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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