Events

Safety Alert for Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ethicon Endo-Surgery.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-12-04
  • Event Date Posted
    2012-12-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121204.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ethicon endo-surgery enseal g2 curved and straight tissue sealer the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning enseal g2 curved and straight tissue sealer, manufactured by ethicon endo-surgery (ees). the affected products could be identified by the following product codes: nslg2c14, nslg2c25, nslg2c35, nslg2c45, nslg2s14, nslg2s25, nslg2s35, nslg2s45. all lot numbers with expiration date from october 2013 through september 2017 are impacted. according to the manufacturer, there is a potential for self-activation while the device is in use, which could result in injury to patients or users (thermal damage). to date, the manufacturer has not received any reports of patient or user injuries. the manufacturer advises all affected users to stop immediately the use of ees enseal g2 curved and straight tissue sealer. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con208680 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 december 2012.

Device

Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery