The serious nature of internal burns allegedly resulting from errant electrical discharge through micro-cracks warrants more serious action along the lines of a product recall.
San Francisco, CA (PRWEB) June 20, 2013
After previously announcing problems with the EndoWrist surgical scissors used in conjunction with the da Vinci surgical robot*, Intuitive Surgical, the maker of the robot and the scissors, has shipped its newest version of the surgical shears.** According to one report, the EndoWrist Monopolar Curved Scissors have been redesigned to ensure that micro-cracks do not form.***
The micro-cracks in the earlier version of the scissors are alleged to pose risk of serious and life-threatening complications during da Vinci-assisted surgery.*** Intuitive Surgical admitted that the microcracks in the EndoWrist attachment “may create a pathway for electrosurgical energy to leak to tissue during use.”**** Because Intuitive Surgical has not issued a recall of its previous surgical shears, some are still in use and may continue to pose a danger to patients undergoing robot-assisted surgery.
The shears are used in a variety of abdominal surgical procedures, mainly to cut and coagulate tissue in surgeries ranging from hysterectomies and prostatectomies to gastric bypass procedures.****
The new shipment of modified scissors comes on the heels of Intuitive Surgical’s May 8, 2013 urgent medical device notification regarding the scissors’ potential to burn patients, as well as its notification to the Food and Drug Administration (FDA) of the same problem.**** Between 2011 and 2012, surgeons’ reports of accidental burns, punctures, and other mishaps (sometimes involving death) associated with the da Vinci system increased by thirty-four percent.****
Attorney William Audet, whose law firm Audet & Partners, LLP represents several plaintiffs allegedly injured as a result of da Vinci surgery, questions the efficacy of remedial action taken by Intuitive Surgical." While discovery of micro-cracks in the monopolar shears, and shipping of replacement units may theoretically reduce the risk of surgical burns in the future, there is no guarantee either that: (a) da Vinci surgeons will replace their old, allegedly defective scissors; or (b) other da Vinci components are free of micro-cracks. The serious nature of internal burns allegedly resulting from errant electrical discharge through micro-cracks warrants more serious action along the lines of a product recall."
If you or someone you know has suffered an injury that may be related to the da Vinci robot or any of its components, please contact Audet & Partners, LLP by calling us toll free at 800.965.1461, or visit our informational website at http://www.davinci-surgical-robot-lawsuit.com.
**Intuitive Surgical ships new surgical scissors following crack warning, (Mass Device, June 6), http://www.massdevice.com/news/intuitive-surgical-ships-new-surgical-scissors-following-crack-warning