Events

Safety Alert for Staples, Staplers and Staples with Stapler

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufacturing Gmbh || Covidien Llc.

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
  • Event ID
    R1705-163
  • Event Number
    2013DM-0010508
  • Date
    2017-05-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=89
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer states that there is the possibility of an incomplete seal on the inner packaging, which may lead to premature degradation of the suture material, the use of products with this condition may increase the suture rupture potential, however this packaging defect does not affect the sterility of the product, leading to the occurrence of possible adverse events on the patient.

Device

Staples, Staplers and Staples with Stapler
  • Model / Serial
  • Product Description
    The reusable staplers have applications in abdominal, gynecology, pediatric and thoracic surgery for resection, cross-sectional and anastomosis creation. They can be used for transverse cutting and resection of the pancreas. The recharge of a solouso has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and the creation of anastomosis. They can be used for transection and resection of the pancreas.
  • Manufacturer
    Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufacturing Gmbh || Covidien Llc

Manufacturer

Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufa...
  • 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
    NIDFSINVIMA