Events

Recall of THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)

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-01240-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01240-1
  • 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 has received complaints of damage to the thunderbeat hand instruments during surgical procedures.These complaints involve the following or a combination of the following descriptions:- cracking and deforming of the thunderbeat probe tip/jaw- partial separation of the ptfe (teflon) pad- exposed metal part due to severe wear of the ptfe padprobe damage detected during surgery will trigger audible and visual generator alarms.
  • Action
    Olympus Australia is providing additional user instructions on procedural techniques to prevent damage to the Thunderbeat hand instruments.

Device

THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)
  • Model / Serial
    THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries) Multiple Models affectedARTG Number: 209954
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd