Duet TRS Loading Units (Used with Endo GIA Universal Staplers and Endo GIA Universal Ultra Staplers) - Urgent Medical Device Recall - Contraindication for Thoracic Use - Notice to Hospitals

Starting date:

January 13, 2012

Posting date:

January 25, 2012

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002594

This is duplicated text of a letter from Covidien Canada.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Endorsed Important Safety Information on Duet TRS Loading Units (used with Endo GIA universal staplers and Endo GIA universal Ultra staplers)

January 13, 2012

Attention: Risk Management Director and O.R Materials Management
Please forward this communication to all surgeons/surgical personnel.

Subject: Urgent Medical Device Recall, Contraindication For Thoracic Use, Duet TRS Loading Units

Dear Customer,

Covidien (formerly United States Surgical, a division of Tyco Healthcare Group, L. P.) is conducting a voluntary Recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units (SULU) with respect to the use of this product family in the thoracic cavity.

Serious injuries and deaths have occurred due to the failure mode associated with this Recall. Covidien has received reports of 3 deaths and 13 serious injuries following the application of Duet TRS™ Loading Units in the thoracic cavity. We have concluded that Duet TRS™ has the potential to injure adjacent anatomical structures within the thorax which may result in life threatening postoperative complications.

Users of Duet TRS™ Loading Units should not use the device in thoracic surgery in both adult and pediatric populations. Users of Duet TRS™ may continue to use Duet TRS™ in other applications. Covidien will be revising the Instructions for Use for the Duet TRS™ to contraindicate the Duet TRS™ for use in thoracic procedures in adult and pediatric populations. In the interest of patient safety we are initiating this Recall in advance of that change.
This Recall only applies to the Duet TRS™ loading units and only for the use of this product in the thoracic cavity. Other Endo GIA™ families of SULUs are not affected.

The affected product codes and descriptions are as follows:

DUET4535
    Duet TRS™ 45 3.5MM
    STRAIGHT SULU

DUET4535A
    Duet TRS™ 45 3.5MM
    ARTICULATING SULU

DUET4548
    Duet TRS™ 45 4.8MM
    STRAIGHT SULU

DUET4548A
    Duet TRS™ 45 4.8MM
    ARTICULATING SULU

DUET6035
    Duet TRS™ 60 3.5MM
    STRAIGHT SULU

DUET6035A
    Duet TRS™ 60 3.5MM
    ARTICULATING SULU

DUET6048
    Duet TRS™ 60 4.8MM
    STRAIGHT SULU

DUET6048A
    Duet TRS™ 60 4.8MM
    ARTICULATING SULU

Required actions:

1. Immediately discontinue use of the device in thoracic surgery.
2. Immediately advise all surgeons/surgery personnel of this Recall.
3. Product intended for thoracic use must be returned. Complete the attached Customer Response Form # 2 and return it to our Product Monitoring Department using the fax number or email address indicated on the form. Covidien Customer Service Department will then contact you with your RGA paperwork for product return and credit.
4. WHETHER OR NOT you will return affected product to Covidien, please complete the appropriate attached form and return to Covidien. Customer Response Form # 1 is your Acknowledgement that you have taken the appropriate action, but will not be returning any product. Your response is vital to our monitoring of the effectiveness of this action.

This action is being taken with the knowledge of Health Canada. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service at 1-877-664-8926, option 1.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious injury or other serious or unexpected adverse incidents for medical devices in patients using Duet TRS™ Single Use Loading Units should be reported to Covidien Canada or Health Canada at the following addresses:

Joseph DiMarzo
Director, Regulatory Affairs and Quality Assurance
Covidien Canada
7300 Trans Canada Highway,
Pointe Claire, Quebec  H9R 1C7
Telephone : 1-877-664-8926

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Sincerely,

original signed by

Joseph Di Marzo
Director, Regulatory Affairs and Quality Assurance
Covidien Canada

[NJS_FILE:6e5a40a6-dfcc-4841-89fd-157b05f7a8d6:21a818a9-998b-450d-996a-7a06723bd999]

DUET TRS™ Loading Unit
Contraindication for Thoracic Use
CUSTOMER RESPONSE FORM # 1
Acknowledgement with no product to return
AS USAGE IS INTENDED FOR NON-THORACIC PROCEDURES

The following information must be completed and faxed to:

Covidien Canada,
Dawn Boyce - RA/QA Dept.
Fax no: 514-695-2379
Email:  dawn.boyce@covidien.com

Date:

Name of Person Completing this form:

Title:

Direct Phone:
Email:

Account Name:
Covidien Account #:

Address:

City:
Prov:
PCode:

How did the account purchase this product?  (Please check)

Direct from Covidien
From a Distributor

Distributor Name:

Address:

City:
Prov:
PCode:

(please sign).

I acknowledge receipt of the duet trs™ Loading unit recall notification dated january 13, 2012 and will not be returning inventory.

DUET TRS™ Loading Unit
Contraindication for Thoracic Use
Customer Response Form # 2 - Product to return

Product intended for thoracic use must be returned.

The following information must be completed and faxed to:

Covidien Canada,
Dawn Boyce - RA/QA Dept.
Fax no: 514-695-2379
Email: dawn.boyce@covidien.com

We have the following affected product in stock and understand that Covidien Customer Service will contact with me with a Return Goods Authorization number: (Covidien Customer Service can be reached at 1-877-664-8926, option 1).

Duet TRS Loading Units - Advisories, Warnings & Recalls for hospitals

Item number	Lot number	Quantity found (eaches)	Customer po #

Hospital Name

Address

City, Province

Contact Name (Please Print)
Title / Department

Signature
Date

Phone Number
Fax Number