Events

Recall of HF Cable used with ESG-400 Electrosurgical Generator (bipolar)

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-2016-RN-01161-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01161-1
  • 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 is notifying users of the reoccurrence of potential error codes for the olympus wa00014a hf cable. although procedures can continue by troubleshooting and clearing error codes in accordance with the esg-400 instructions for use (section 8.2), olympus is highlighting instances of the following error codes when the device is connected: - e618 ‘data transfer’, - e486 ‘no instrument connected’; or, - a pop up message ‘use default instrument settings’ there have been no australian reports of these error codes or incidents with patient injury worldwide. error codes typically only occur in the rare event of rapid activation, such as re-activating the esg-400 electrosurgical generator within 0.2 seconds after the last activation.
  • Action
    Olympus is advising users that if the error occurs, to troubleshoot as per the Instructions for Use (IFU) to continue the procedure, and notify Olympus to obtain a replacement cable. This action has been closed-out on 12/05/2017.

Device

HF Cable used with ESG-400 Electrosurgical Generator (bipolar)
  • Model / Serial
    HF Cable used with ESG-400 Electrosurgical Generator (bipolar)Product Code: WA00014A ARTG Number: 194874
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd