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U.S. Department of Health and Human Services

Class 2 Device Recall EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology

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  Class 2 Device Recall EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology see related information
Date Initiated by Firm April 09, 2018
Create Date April 26, 2018
Recall Status1 Terminated 3
Recall Number Z-1528-2018
Recall Event ID 79905
510(K)Number K083781  
Product Classification Staple, implantable - Product Code GDW
Product EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560

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.
Code Information Lots: N7K0694MX, N7L1078MX, N7M0837MX
Recalling Firm/
Manufacturer
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
800-962-9888
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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
Quantity in Commerce 475
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN
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