Events

Recall of Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)

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-00142-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00142-1
  • 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
    A problem has identified a problem with the diego elite tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. if the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. at this stage, no reports of injuries relating to the drive shaft disengagement have been received.
  • Action
    Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or replacement stock.

Device

Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and sucti...
  • Model / Serial
    Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)Item Codes: TS100S and TS101DCMultiple Lot Numbers ARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd