Events

Recall of Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Matrix Surgical 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-2014-RN-00020-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00020-1
  • 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
    This is a follow up to an earlier recall (tga reference: rc-2012-rn-00637-3) where the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube. the manufacturer has determined that the safest maximum operating level for the diathermy spatulas is 30 watts.
  • Action
    Matrix Surgical is advising users to quarantine affected stock for return to Matrix Surgical for replacement or credit note. Updated Instructions for Use (IFU) will be provided to all users along with the newly supplied devices. This action has been closed-out on 11/02/2016.

Device

Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)
  • Model / Serial
    Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)Product Code: UFPS-133057Lot Numbers: 817101080, 8081106264Product Code: UFPS-133058Lot Numbers: 8191203108, 8191206116, 8191208096, 8191211137, 8191305131, 8191309178Product Code: UFPS-145058Lot Numbers: 8301012171, 4871304081, 830100357ARTG Number: 169175
  • Manufacturer
    Matrix Surgical Pty Ltd

Manufacturer

Matrix Surgical Pty Ltd