Recall of EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-00328-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-17
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 identified an increase in adverse events with enseal g2 superjaw for suspected thermal injuries related to the use of the device.
  • Action
    Johnson & Johnson Medical (JJM) is updating the instructions for use to prevent the issues from occurring in the field. JJM has advised the TGA that they are further reviewing the post-market surveillance data and will advise the TGA regarding the outcomes of this review.

Device

  • Model / Serial
    EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)Product Code: NSEALX22LARTG Number: 165469
  • Manufacturer

Manufacturer