“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised. Patient safety is our first obligation.”
Abstract
Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity. This follows reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity
Background
Launched in 2009, the Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.
Reason for action
Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. The Company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.
“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.”
Affected Products
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
What happens next?
Covidien is working with the United States Food and Drug Administration (FDA) and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the Company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use. Additionally, it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.
“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised,” said Hanson. “Patient safety is our first obligation.”
Customers have been notified of this recall by letter on January 12, 2012 and asked that product intended for thoracic use be returned following contact with Covidien to receive return goods details.
Source: Covidien
published: January 16, 2012 in: Covidien, News, Recalls, Regulatory, Thoracic/Respiratory