Events

Recall of ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec 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-2014-RN-00522-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00522-1
  • 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 advised they have received complaints that the electrode gel may make contact with an internal staple causing no output, sparking and heat build-up between the staple and the electrode foil contact surface. whilst there have been no complaints and no reports of injury or death received by the product sponsor in australia, one patient in japan was reported to have received a skin tear.
  • Action
    ConMed is requesting their customer to immediately discontinue the use of the device and arrange for its return. This action has been closed-out on 29/01/2016.

Device

ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

Manufacturer

ConMed Linvatec Australia Pty Ltd