| Class 2 Device Recall EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology | |
Date Initiated by Firm | April 09, 2018 |
Create Date | April 26, 2018 |
Recall Status1 |
Terminated 3 on May 12, 2020 |
Recall Number | Z-1527-2018 |
Recall Event ID |
79905 |
510(K)Number | K083781 |
Product Classification |
Staple, implantable - Product Code GDW
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Product | 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. |
Code Information |
Lots: N7J1145MX, N7L0380MX, N7L0762MX, N7L1077MX, N7M0733MX,N7K0092MX, N7L0457MX, N7L0868MX, N7M0144MX, N7M0835MX, N7K0692MX, N7L0594MX, N7L0940MX, N7M0185MX N8A0144MX, N7K0693MX, N7L0676MX, N7L1076MX, N7M0732MX, N8A0166MX |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
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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 | 5547 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = GDW
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