U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Staple, implantable - Product Code GDW
원인
Potential for failure of the device safety interlock. the safety interlock prevents an empty single-use loading unit from being fired a second time.
조치
All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
“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.