Da Vinci Robot Replacement Scissors Shipped By Intuitive Surgical
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 microcracks do not form.**
The microcracks in the earlier version of the scissors had the potential to cause 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.***
While the new scissors are a step in the right direction, the older version of the surgical shears remains in operating rooms across the nation. It is still unknown whether these new scissors will have problems of their own, or even whether surgeons will replace their old shears with the modified versions.
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. Alternatively, please complete and submit our confidential inquiry form on the right side of this page. Please act now, since the law may limit your right to recovery if you delay.
*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
** Update on Da Vinci Surgery Lawsuits: Replacement for Potentially Defective Hot Shears Shipped, Intuitive Surgical Says (Bernstein Liebhard June 13, 2013), http://www.davincisurgery-lawsuit.com/replacements-shipped-for-hot-shears-that-could-cause-robotic-surgery-complications/
***da Vinci Burn Warning Prompts Intensified FDA Review, (Audet & Partners), http://www.audetlaw.com/index.php/news_detail/da_vinci_burn_warning_prompts_intensified_fda_review