Events

Safety Alert for Endo Peanut 5 mm Device

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

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
    2017-05-19
  • Event Date Posted
    2017-05-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170520a.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: medtronic endo peanut 5 mm device medical device manufacturer, medtronic, has issued a medical device safety alert concerning its endo peanut 5 mm device. [item code: 173019; lot numbers: m5k04x to m7a01x; expiration: october 2020 through january 2022]. according to the manufacturer, the voluntary recall is being conducted following reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process. the use of products with this issue may increase the potential for the tip to disengage resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. while four reports indicate that patients required an intraoperative x-ray to locate the disengaged tip, and in one case the tip was not retrieved subsequent to x-ray, no patient injury or impairment has been reported. the manufacturer requests customers to quarantine and return any unused products.. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2017.

Device

Endo Peanut 5 mm Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Endo Peanut 5 mm Device
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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