Events

Recall of Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)

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-2013-RN-00680-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00680-1
  • 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
    Olympus has received a small number of reports where the pump may be supplied with the pump head in the unlocked position. if the pump head is unlocked, this may cause the pump to stop and go into stand-by mode. as a result, no water will be delivered to the endoscope.
  • Action
    Olympus are requesting users to discontinue use of the affected devices. An Olympus Field Service Technician will perform an inspection and modification if required. Olympus is also providing inspection and modification instructions should the end user wish to correct the device. At the time of agreement 17 customers had received the correction. These customers have been provided with the product correction information for their records.

Device

Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)
  • Model / Serial
    Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)Multiple Lot Numbers affected.ARTG Number: 145859
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd