While the U.S. Food and Drug Administration investigates a spike in adverse-event reports that it received in regard to the robotic da Vinci Surgical System, the manufacturer told the FDA and hospitals that a potential system malfunction could burn a patient’s organs.
The Intuitive Surgical Inc. “Dear da Vinci Customer” letter dated May 8 informed hospitals that precautions should be taken to prevent some of the Hot Shears Monopolar Curved Scissors from sending a charge from its “micro-cracks” into a patient’s tissue.
The illustrated letter reads that certain versions of Hot Shears “may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. This may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury. The affected area … is confined to an approximately 1 cm section of the shaft, as indicated. These micro-cracks may not be visible to the user.”
The da Vinci system has been involved in numerous procedures after which patients died, according to reports submitted to the FDA. One comprehensive review of the FDA’s voluntarily submitted summaries was performed by Citron Research, which provides stock commentary. Looking into the FDA’s adverse-event reports to compile its own investors alert, Citron, as this space noted on May 2, found “dozens of death outcomes within thousands of da Vinci adverse-event reports submitted to the FDA.”
Da Vinci robotic surgery lawsuits have been filed on behalf of victims or their families. The experienced medical device attorneys at Reich & Binstock (www.reichandbinstock.com) represent such plaintiffs now and offer free consultations to others who may have been victimized. The law firm may be reached toll-free at 1-866-LAW-2400.
“In 2000, the da Vinci Surgical System became the first robotic surgical platform commercially available in the United States to be cleared by the FDA for use in general laparoscopic surgery,” according to Intuitive Surgical. The system is installed in more than 2,000 hospitals worldwide.
From a console away from the operating table, the da Vinci surgeon controls the system’s robotic arms and sees the progress through a three-dimensional viewer. The system helps surgeons to perform cardiac, thoracic, urologic, gynecologic, pediatric, general, and transoral surgery.
CNBC reported on the manufacturer’s customer correspondence as a part of its continuing investigative reporting on the robotic surgical system.