Events

Safety Alert for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier

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
    2013-05-07
  • Event Date Posted
    2013-05-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130507.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 ligaclip 10mm m/l endoscopic rotating multiple clip applier the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning ligaclip 10mm m/l endoscopic rotating multiple clip applier manufactured by ethicon endo-surgery, llc (a johnson & johnson company). the affected code number is er320 (with expiration dates from november 2016 to march 2018). the manufacturer has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure. product recall of affected units is on-going. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00396-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 may 2013.

Device

LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery