Events

Recall of Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments

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-2017-RN-00757-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00757-1
  • 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 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
  • Model / Serial
    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