Robotic Surgery Injury and Litigation
Patients Are Being Injured By Robotic Medical Devices During Surgery
Have you been injured by a robotic medical device during a medical procedure? Common types of surgeries involve gynecological procedures such as hysterectomies. Use is also common for prostate and urological surgeries.
Our firm is investigating and litigating claims on behalf of patients injured by robotic surgery, which may be against the company which manufactured the robotic surgical device or the physician who did the procedure. In some suits, both parties may be included.
da Vinci Recall Notification and Surgical Usage Precautions
May 8, 2013: Intuitive Surgical made an "Urgent Medical Device Notification" relating to the hot shears (also called monopolar curved scissors) on the da Vinci robot due to the risk of stray electricity leaking to organs and tissue, causing thermal burns. (Notification #2955842-05-07-2013-005)
The significance of this recall is much broader than just the alleged basis for the notification-micro-cracks found in a few arms. The recall notice, when read carefully, demonstrates what we have claimed all along in our New York State groundbreaking McCalla case and others, that there is a serious risk that the use of monopolar current in the da Vinci robot machines will cause burns t o tissue. Such burns may go undetected during surgery and manifest themselves only later when reoperation is needed and permanent damage or death may have occurred.
In fact, the recall notice contains an attachment which outlines the risks of burns. This is useful legally both in showing what doctors should be alert to and may be doing wrong, and what has been concealed from doctors by Intuitive up to now. These points are:
*don't do "air firing" -allowing a gap between the scissors and the tissue, as this allows the current to arc to other tissue
*watch out for burns below or behind the operative field the surgeon can see (by inspecting after doing the surgery)
*be careful using in patients who are more susceptible to electrical burn, such as ones who have had radiotherapy.
*do not exceed a certain maximum in energy setting on the monopolar hot shears as this will lead to thermal burns.
Contact us today online or by telephone at 888-335-9457 to speak with a knowledgeable and nationally recognized robotic surgery lawyer.
Common types of injuries due reported, particularly to the FDA are: burns, tears of the intestines, punctured blood vessels or ureters, severe injury to the bowels, vaginal cuff dehiscence, excessive bleeding, and death. Injuries can be exacerbated because of delayed diagnosis.
At Rheingold, Valet, Rheingold, McCartney & Giuffra LLP, we help people who have been injured by faulty medical devices, such as Intuitive Surgical's da Vinci Surgical System.
Cutting and cauterizing the internal organs is accomplished by electrical current which is passed through robotic instruments. Due to the use of monopolar energy (as opposed to bipolar energy), increased the risk of burns occurs. This results from current which jumps from the instrument to the body part.
The surgical device is known as the "da Vinci," manufactured by Intuitive Surgery,Inc., a California company. While literature touts a good safety record, there are instances where the robot has not responded to doctors' commands. Another issue has been inadequate training on the machine. Surgeons may fail to notice that the machine caused an insidious complication.
Product liability suits against Intuitive Surgical may allege: improper design of monopolar circuits and failure of the insulating barriers. Also to be considered is failing to train surgeons how to use the da Vinci properly
Our attorneys have successfully handled numerous faulty medical device lawsuits and have won many verdicts and settlements for people who have suffered. We offer our clients personal, attentive and individualized service from a skilled team of attorneys.
Contact Us for a Case Evaluation
Have you or someone close to you been harmed by a robotic surgery? Please contact us today online or by telephone at 888-335-9457 to speak with an experienced New York patch recall lawyer. Our law office is conveniently located in a brownstone in Midtown Manhattan located at 113 East 37th Street.
For more information, please visit our robotic surgery information center.
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4/4/2012
INTUITIVE SURGICAL SUED IN NEW YORK FOR DEATH ARISING OUT OF USE OF ITS DA VINCI ROBOT
The father of his deceased 24 year old daughter has commenced a lawsuit in New York against Intuitive Surgical, Inc., the maker of the da Vinci surgical robot, alleging that the device caused her death.
In his complaint, filed by the firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP of New York City, Gilmore McCalla asserts that when his daughter was having a hysterectomy in Bronx hospital in August 2010, the robot caused burns to an artery and her intestines, which led to her death two weeks later.
The complaint alleges design flaws in the da Vinci robot, including un-insulated surgical arms and use of electrical current which can jump to healthy internal organs and tissue. It also alleges that physicians are not properly trained on the device, and that Intuitive Surgical has failed to run randomized tests as to complications with its robot.
The McCalla complaint, filed in the federal court in New York City on April 4, 2012, 12civ2597, also asserts that the manufacturer has suppressed reports of complications, and has oversold the merits of its da Vinci robot to hospitals considering buying it. The machine costs of upwards of $2 million to purchase and then has a sizeable annual maintenance cost.
McCalla is also asserting, in separate litigation, that the surgeon operating the robot and the hospital where the procedure was being done were careless, in part in not discovering the damage done by the robot.
The da Vinci robot is operated remotely from a console by a surgeon. Several arms are placed into the patient, for burning away tissue in order to remove the diseased organ, and also for a camera.
Numerous complications have been reported in medical journals with the use of the da Vinci robot in various types of surgery, not only hysterectomies as in the McCalla case but also other gynecologic surgery, and prostate surgery. The common types of injuries are tears and burns, to blood vessels, intestines, uterus and vaginal cuff dehiscence. Often these injuries are delayed in their appearance after the actual surgery.
Intuitive Surgical, Inc., is headquartered in Sunnyvale, CA. It is currently the sole manufacturer of surgical robots in the country. Its stock is traded on the NASDAQ exchange under the letters ISRG. Recent annual earnings were more than $1.75 billion and its balance sheet showed more than $3 billion in assets.
The cost for performing robotic surgery greatly exceeds the type of laparoscopic or open surgery it replaces, and there has been debate in the medical literature whether the extra costs-whether paid by insurance companies, the government or patients-is justified because of claimed better outcomes with the device. The complaint alleges that Intuitive Surgical has not sponsored any comparative safety tests where patients are selected prospectively as compared to just looking at results.
In evaluating the cost-benefit ratio in the use of expensive robotic surgery, some medical groups have questioned the use of robotic surgery. These include the American College of Obstetricians and Gynecologists; and the Kaiser Foundation.
In certain instances where there are complications while performing robotic surgery, it may be necessary to sue both the robot manufacturer and the surgeon, who may have been careless in operating the machine. That is the true of the McCalla litigation. However, often the surgeon has not been properly trained by Intuitive Surgical on the use of the machine and so may not realize that burns and tears are being inadvertently caused.
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP is a plaintiffs law firm in New York handling national litigation involving defective medical drugs and devices. Currently it is involved in mass litigation involving the NuvaRing birth control device, the Yaz birth control pill, the DePuy ASR metal-on-metal hip replacements, femur fractures in Fosamax users, among other suits. The firm also handles medical malpractice cases.
