Covidien, a ten billion dollar medical materials manufacturer, issued a recall notice for The Duet TRS single-use cartridges. These cartridges which are used with the Endo-GIA stapler have been definitively linked to three deaths in thoracic surgery patients, and several serious injuries. The mechanism of injury (according to the company) appears to be related to some ancillary material within the staple cartridges. Unfortunately, while amending their initial statement to state that the device “has the potential to injury tissue”, further information about the problem has not been forthcoming from the manufacturer, leading many surgeons to question to true estimates of injury, particularly given the gravity of the warnings the company has issued. The revised warning also now lists thoracic surgery as a contraindication to use of this device.
Surgical staplers such as the Endo-GIA have revolutionized the field of surgery, and are particularly helpful in thoracic surgery by simplifying surgical resections. Instead of suturing and oversewing incisions after a wedge resection of a lung lesion, for example – the stapler allows the surgeon to cut and close the incision in one manuever. This is particularly helpful in thoracoscopy (and laparoscopy in general surgery) where surgeons are working through a limited space. (Compared to the abdominal cavity – the chest cavity is a relatively inflexible space due to the rib cage – which limits maneuverability, particularly when working thru small ports instead of open incisions*).
A list of the recalled staple cartridges can viewed here. This information is more important for surgeons overseas, as recalled items are often re-sold to secondary markets.
* There are specialized thoracoscopy tools – long narrow tools to allow surgeons to suture, cut, grasp tissue within the chest thru small (1 to 1.5 cm_ incisions (ports).
Additional references to this story:
Coviden recalls device after 3 deaths, multiple injuries in thoracic patients.
Coviden staples contraindicated in thoracic surgery.
Update: 1/17/2012 – 1630: Looks like we scooped Medscape on this story!
2 thoughts on “Endo GIA staple recall”
As a patient on whom the staples were used, I find it appalling that Covidien has informed its “customers”, the surgeons, little or nothing about the kinds of “serious injuries”, the duration of a threat of injury and/or death, proposed revisions or other courses of treatment, care, observations or precautions, etc. Absolutely nothing has been stated other than the shattering news of 3 deaths and 13 serious injuries among ??? or relatively few patients.
Agreed. In fact, in my review of the available information – only a hint of the possible cause / mechanism of injury has been suggested.. “injuries related to material within staples” – is this an acute allergy reaction? is this acute dehiscence of stapled material? tissue necrosis? surgeons/ patients alike need to know..