FDA Issues Notices for Intuitive Surgical da Vinci Vessel Sealer
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
The advances in surgical technique over the past few decades have been remarkable. Besides for new types of procedures old procedures are being done in less invasive ways to minimize the risk of complications. More recently, robotic surgery has made strides in becoming more used and well accepted in the surgical field. Using robotic surgery has the potential to improve accuracy and reduce the invasive quality for a host of surgical procedures. Yet, to be successful, the robotic systems must be designed flawlessly for surgeries to have the desired effect. As of yet, this has not been the case. Intuitive Surgical, one of the leading players in the robotic surgery industry has repeatedly faced regulatory issues and recalls because of flawed design and system malfunction.
After being cleared in January 2012, the Food and Drug Administration has issued recalls recently for the EndoWrist One Vessel Sealer, noting that it may cause short-term or medically reversible adverse health effects. To aid in overcoming the obstacles of robotic surgery, the FDA is holding a workshop in late July about robotically assisted surgical devices.
Intuitive Surgical initiated a voluntary corrective action for the da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer after identifying the potential for a small portion of the vessel sealers to provide insufficient energy delivery when used on thin vascular tissue. The FDA advises customers to examine the machines by re-checking tissue after the seal cycle is designated as complete. If ensuing re-grasping and re-sealing attempts are not successful, the FDA recommends an alternative means of sealing be used.
Nearly 3,300 EndoWrist Vessel Sealers are associated in the ongoing recalls, which were distributed in the U.S. as well as over 20 countries worldwide.
Our senior partner Paul Rheingold was the first New York state litigator to file suit against da Vinci and resolved many claims against them. These robotic machines are also involved in medical malpractice claims which we investigate on behalf of new clients http://www.rheingoldlaw.com/Medical-Malpractice-Overview/Robotic-Surgery-Malpractice.shtml.