Surgical staples discontinued after patient injuries and deaths
Published date : 23 August 2012
Article date : 23 August 2012
Covidien has discontinued certain Duet TRS single-use surgical stapling systems after reports of patients deaths and injuries. The medical device company removed the Duet TRS Universal Straight and Articulating Single-Use Loading Units from the market following a report linking the tissue reinforcement devices to a post-operative injury. This is in addition to 13 serious injuries and 3 patient deaths that spurred a recall and FDA warnings of possible mismanagement of the recall.
In January, Covidien recalled all of its Duet TRS single-use heads for thoracic surgery, modifying the product's instructions and warning against use in thoracic procedures. Covidien reported that the device has the potential to injure adjacent anatomical structures within the thorax which may result in life-threatening post-operative complications. The manufacturer also placed a hold on the global Duet TRS inventory in order to conduct the relabeling.
Then, in June, the FDA asked Covidien to defend its management of the recall and remarked on a lack of sufficient documentation and delayed response to reports which were first noted more than 2 year before the recall took place.
The recall and the new notice affect 8 models of straight and articulating Duet cartridges which are endoscopic stapling systems with preloaded tissue reinforcement material. The cartridges attach to GIA universal stapler handles. Covidien has sold more than 540,000 units worldwide.
This week, Covidien has also recalled grounding pads contained in ablation device kits after at least 4 patients experienced serious injuries and burns at the pad site.
Source: Mass device, 22 August 2012
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