In July, 2013, the FDA issued a Class II recall on the da Vinci Surgical Robot system. Class II recalls are initiated where a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The da Vinci robots, manufactured and designed by Intuitive Surgical Inc. (ISI), are used in minimally invasive surgeries and allow a surgeon to use a magnified vision system and tiny instruments designed to be more maneuverable than a human wrist. The idea is that the da Vinci Surgical Robots will allow a surgeon to be even more precise during procedures, reducing the risk and harm to the patient. Numerous problems with the design and operation of these robots, however, are being discovered in operating rooms across the country.
In November, 2013, the FDA issued a damaging report concerning the safety of the da Vinci Surgical Robots. The report, which resulted from a survey of surgeons, detailed malfunctions and problems with the surgical robots, including failure of the arms to recalibrate to appropriate settings, failure of arms to make correct cuts and electrical arcing of components – all of which could be potentially dangerous or life threatening to a patient. Surgeons offered several suggestions to improve da Vinci Surgical Robots, including changes to the design of the machine and changes to the training program.
In December, 2013, the FDA announced a recall of 1,386 da Vinci systems following ISI’s issuance of an urgent Field Safety Notice detailing problems with the instrument arm of the system, resulting in friction that can interrupt the motion of the arm and lead to inaccurate and potentially dangerous surgical cuts during a procedure. ISI’s Field Safety Notice indicated that it had received one such report where the interrupted motion resulted in an “imprecise cut” during the transection of a patient’s urethra. Since its initial recall in July, 2013, the FDA has since issued several additional Class II recalls regarding the da Vinci Surgical Robot system and its components parts. It appears even more recalls may be on the way, which could lead to hospitals and surgeons curtailing their use of these machines.
In 2013, 3,697 adverse event reports concerning da Vinci Surgical Robots were submitted to the FDA – an increase of over 100% from 2012. These reports involved incidents of malfunction, injuries to patients and even death. The number of lawsuits against ISI continues to grow based on the fact that approximately 400,000 surgeries in 2012 involved a da Vinci Surgical Robot. The personal injury attorneys at SUGARMAN have a history of investigating and successfully litigating product liability cases involving medical devices such as the da Vinci Surgical Robot system. If you have sustained injuries during a surgical procedure that was caused by a malfunction of one of these surgical systems and wish to speak to an attorney, please fill out a Contact Form, call us at (617) 542-1000 or e-mail email@example.com.