Patient Deaths Prompt Recall of Thoracic Staples
Three deaths and 13 serious personal injuries have led to the voluntary recall of endoscopic surgical staples used in thoracic surgery. Last week, Covidien, a global manufacturer of medical devices and healthcare products, issued a voluntary recall of Duet TRS Universal Straight and Articulating Single Use Loading Units (surgical staples), advising against their use in thoracic surgery.
According to the Food & Drug Administration (FDA) recall notice, Covidien “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.”
Since its FDA approval in 2009, more than 500,000 Duet TRS units have been sold worldwide. The medical device received FDA approval under 510(k) clearance which does not require human testing. Such fast-track approvals are allowed when a new medical device is substantially equivalent to a product currently on the market.
Covidien has estimated that thoracic surgeries comprise one-third of the uses for Duet TRS. Thoracic surgery treats tissues and organs in the chest, including the heart, lungs, diaphragm, esophagus and trachea. Thoracic surgery is most commonly performed to treat chest trauma, lung cancer, esophageal cancer, emphysema and lung transplants.
If you have recently had thoracic surgery, contact your surgeon to see if Duet TRS was used in your surgery. If you or a loved one has experienced complications following thoracic surgery, a Missouri product liability lawyer can review your case and advise you of your legal rights.