Events

Recall of Intuitive Surgical Version 12 Tip Cover for 8mm Monopolar Curved Scissors (endotherapy scissors)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2012-RN-00854-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00854-3
  • 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
    During the manufacturing process, the sealed edge may not have been uniformly formed and pleats or creases may have been formed which could have the potential to compromise the barrier integrity of the pouch.
  • Action
    Identify and quarantine affected products. Return the quarantined stock to Device Technologies for replacement stock or credit.

Device

Intuitive Surgical Version 12 Tip Cover for 8mm Monopolar Curved Scissors (endotherapy scissors)
  • Model / Serial
    Intuitive Surgical Version 12 Tip Cover for 8mm Monopolar Curved Scissors (endotherapy scissors)Part Number: INS-400180 version 12Multiple lots affectedARTG Number: 97369
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd