Events

Recall of 10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Applied Medical 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-00387-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00387-1
  • 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
    Due to inconsistent clip application, the 10mm direct drive clip applier is being recalled. although malformed clips are typically readily apparent to the user, this failure mode may lead to unoccluded vessels.
  • Action
    Applied Medical is advising users to check inventory for the affected lots and return any affected product. This action has been closed-out on 30/01/2017.

Device

10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopi...
  • Model / Serial
    10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)Product Code: CA090Affected Lot Numbers: 1190181 to 1265006Expiry date: Prior to 18 March 2019Affected Kit Product Codes: CK304, GK306, GK307, GK311, GK312, GK317, GK318, GK323, GK334, GK335, K0509 and K0592ARTG Number: 221008
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd