Events

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

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-2015-RN-00991-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00991-1
  • 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
    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 ...
  • Model / Serial
    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