Events

Safety Alert for Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Covidien Private Limited.

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
    2013-02-08
  • Event Date Posted
    2013-02-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130208a.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: covidien endo gia autosuture universal loading unit 30mm-2.0mm medical device manufacturer, covidien private limited issued a medical device safety alert concerning endo gia autosuture universal loading unit 30mm-2.0mm. the affected product code is 030450 and the affected lot numbers are n2f0563lx, n2f0341lx, n2f0725lx and n2e0605lx. covidien has received one report of adverse event where a single use loading unit contained two staples loading in each cartridge pocket. this condition may result in difficulty firing and removing the device from the application site, which may require medical intervention. according to the manufacturer, no post-operative complications related to this condition have been reported. covidien recommended the affected users to: immediately quarantine and discontinue use of the affected devices immediately advise all covidien endo gia autosuture universal loading unit 30mm-2.0mm users of this recall return the affected products to your supplier the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 february 2013.

Device

Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Covidien Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm
  • Manufacturer
    Covidien Private Limited

Manufacturer

Covidien Private Limited
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH