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
There is a potential for improper welding of the yellow staple guide to the instrument. use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
조치
Notification letters were distributed on 4/9/18. The letters instructed customers to:
Medtronic requests that you quarantine and return any unused products of the item codes and lots detailed above. Unused products from the affected item codes and lots should be returned as described in the Required Actions section below. If you have distributed Covidien EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned.
Required Actions:
1. Please quarantine and discontinue use of the affected item code and lots listed on page one.
2. Please return affected product as indicated below.
3. Complete the Recalled Product Return Form even if you do not have inventory.
Purchased directly from Medtronic:
Complete the Recalled Product Return Form and fax to: 800-895-6140
Ship affected product with RGA# provided by Customer Service to:
Medtronic
Attn: Field Returns
195 McDermott Road
North Haven, CT 06473 USA
Complete form and check the box indicating no inventory
Fax to 800-895-6140 or email to feedback.customerservice@Covidien.com
Exception: Customers with zero inventory, fax to 203-492-7719 or email to FCAMITG@Covidien.com
Purchased from a distributor:
Complete all fields on the form and contact your distributor directly to arrange for return of product
Complete form and check the box indicating no inventory
Fax to 203-492-7719 or email
FCAMITG@Covidien.com
Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA. The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Indonesia, Italy, Korea, Malaysia, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, UK, and Vietnam.
제품 설명
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 || Product Usage: || The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
“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.