Another Product Recall Issued for Da Vinci® Surgical Robots
Last week, the FDA issued a Class 2 Recall on approximately 30 Da Vinci® Surgical Robots after one of the affected devices was discovered to be malfunctioning.
This latest recall comes after a May 2013 manufacturer’s warning that certain components used in the Da Vinci® Surgical Robots – called “hot shears” – may be prone to develop micro-cracks. These micro-cracks could allow electrosurgical energy to “leak” to surrounding tissue, causing thermal injury to internal organs. Moreover, according to another report, the FDA began surveying surgeons after a rise in adverse event reports, which included 70 deaths involving the Da Vinci® Surgical Robot since 2009.
The Da Vinci® Surgical Robot is manufactured and marketed by Intuitive Surgical, Inc. It is used in a number of surgical procedures across the country, including hysterectomies, gastric bypasses, prostate removals, gallbladder removals, and thyroid cancer surgeries. In conjunction with these safety concerns, Intuitive Surgical faces an ever-increasing number of lawsuits brought by patients who have experienced burns, tears, and other serious – and even deadly – injuries.
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