da Vinci Robotic Surgery Lawsuit- When Robots Err

“Science can amuse and amaze us all, but engineering is what transforms the world”, as Isaac Asimov noted in I, Robot.

Imagine a scenario where human ability meets robotic elegance. What was once thought to be a fantasy is now being used in operating rooms all over the world. Let’s dive into robotic-assisted surgery and da Vinci robotic surgery lawsuit.

What is robotic surgery?

Robotic surgery is an advanced method of minimally invasive surgery that uses computer-controlled robots to accomplish tasks that humans are unable to perform or give better outcomes.

A robotic surgery is carried out by a surgeon who has undergone training in the same. Through fellowships in robotic and minimally invasive surgery, some surgeons pursue professional education.

History of Robotic Assisted Surgery

When was the da vinci robot invented?

The idea of robotics used for surgery was conceived more than 50 years ago. NASA tested the concept of telesurgery, or remote surgery, as a potential method of support for astronauts while they were stationed on the space station during the 1970s.

A comparable investigation was conducted on telesurgery for long-distance armed forces surgery by the United States Defense Research Advanced Projects Agency.

The era of robotic surgery started in 1980s when the first robotic assisted surgery was conducted. The first robotic surgery was done using the surgical robot, PUMA 560, for a brain biopsy. In 1988, a transurethral prostate surgery was conducted using the PROBOT, a device developed at the Imperial College London. Robodoc (Integrated Surgical Systems, Sacramento, CA), the orthopedic image-guided system developed by Hap Paul, DVM, and William Bargar, MD, was later used in prosthetic hip replacement.

Engineers came up with three separate systems that merged laparoscopic technology with surgical robots by the late 1990s. The da Vinci Surgical System, the AESOP, and the Zeus Surgical Systems were the three systems integrated in these types of procedures.

Why robotic assisted surgery?

Robotics were being employed at the time of the first robotic surgical procedure in 1985 was to lessen movement resulting from hand tremors.

Along with numerous other advantages specific to each surgical area of expertise, robots provide stability, accuracy, integration with contemporary imaging innovations, a wider range of motion, and telesurgery.

When compared to traditional techniques, surgeons who use the robotic system find that it improves flexibility, and control during the process and gives them a better view of the surgical location.

Robotic Assisted Surgery Statistics

With a surge in the number of cases conducted each year, RAS has already established itself as the gold standard in many institutions across the United States for non-trauma-related surgery.

Around 644,000 robotic-assisted surgeries were carried out in the United States in 2017, according to data from the da vinci robot manufacturers. More robotic-assisted procedures are carried out in the US than in any other nation in the world. Additionally, 73% of all robotically aided cases performed globally and 65% of all da Vinci robotic devices carried out worldwide are in the United States.

In 2022, 600,000 robotic-assisted surgical procedures were conducted in the U.S. The robotic surgery market is anticipated to witness a massive hike of 1 million procedures by 2028.

The market for surgical robots was valued at USD 6.3 billion in 2022, and it is anticipated to have a Compound Annual Growth Rate of 15.9% between 2023 and 2032.

How does robotic assisted surgery work?

Robotic systems have no ability to “think” autonomously. Without the surgeon’s direction, it is powerless to function. It only responds to the exact hand and finger movements made by the doctor performing the surgery. The instruments inside your body move in exact synchronization with the motions of the surgeon.

The procedure of robotic assisted surgery involves robotic-assisted surgery devices, which is carefully operated by a trained surgeon. The main components in the robotic surgery system are surgeon console where the surgeon sits to control the instruments in high-definition 3D.  The next one is the patient cart that holds the camera and instruments that move as per the surgeon’s controls from the console. Another vital component is the vision cart that communicates between other components and supports the 3D high-definition vision system.

The below-mentioned are the general steps followed in the surgery.

• The surgeon makes one or more small incisions, depending upon the surgical procedure planned
• The physician then inserts ports through these incisions.
• Instruments are subsequently introduced through these ports that are attached to the robot.
• One of the ports is used for inserting an endoscope, which is a long, thin camera that delivers 3D high-definition images to the surgery team
• The other ports are employed for insertion of surgical instruments, allowing the physician to carry out the procedure
• Sitting at a panel a few feet away, the physician handles the robotic arm. An assistant remains by his side to assist the surgeon by swapping out the instruments as needed.

Robotic Assisted Surgery Pros and Cons

Now we will glide through the advantages and disadvantages of robotic-assisted surgery.

Robotic Assisted Surgery Benefits

“The robot is a magnifying glass for the surgeon, enabling us to perform complex operations with enhanced precision and control. It’s a game-changer.” – Dr. Thomas Lendvay.

Given how simple it is for surgeons to avoid nearby nerves and organs, one of the main advantages of robotic assisted surgery is that it could give better results and avoid complications in delicate or intricate surgical procedures.

In a nutshell, the advantages to the surgeons while performing robotic surgeries are as follows.

• Greater visualization
• Enhanced dexterity
• Greater precision

Let’s now find the benefits to patients while undergoing robotic assisted surgery.

• Reduced pain and utilization of painkillers
• Less bleeding
• Lower danger of infection
• Less scars
• Shorter stays in the hospital
• Shorter time for recuperation

Drawbacks of Robotic Assisted Surgery

The following are the robot assisted surgery disadvantages which involves risks of robotic surgery.

• Robotic surgery facilities are only available at centers with the adequate funding and surgeons with appropriate training
• Accidental burn injuries can occur when the electrical current in the robotic device leaves the robotic arm and is applied improperly to tissue nearby
• If there are issues, your surgeon might have to switch to an open operation with larger incisions. These include surgical scar tissue that makes it harder for robotic technology to execute the surgery
• Robotic surgery takes longer than non-robotic surgery to be performed at surgical facilities with lower robotic volume or by poorly trained surgeons
• One of the robotic assisted surgery side effects is the risk of compression and nerve injury when compared to traditional surgeries
• Robotic failure may occur, though it is exceedingly rare

Cost of Robotic Surgery vs. Traditional Surgery

Does robotic surgery cost more than traditional surgery?

Yes, robotic assisted surgery cost is higher than non-robot-assisted surgery.

The average expense of a surgical robot is over $2 million. The supplies and equipment needed for robotic surgery are approximately $866 more expensive per procedure than for traditional surgery.

The cost of buying and replacing disposable accessories for each robot, such as scissors, is an additional cost. The continual requirement to repair surgical tools also drives up the overall cost of robotic surgery.

The long-term health advantages of robotic surgery may someday make it worthwhile, despite the procedure’s expensiveness.

Leading Robotic Surgery Companies in the U.S.

• Intuitive Surgical
• Stryker
• Smith & Nephew
• Accuray
• Medtronic
• Globus Medical
• Johnson & Johnson
• Zimmer Biomet

Robotic Surgery and Medical Malpractice Lawsuits

Robot-assisted surgical procedure-related medical malpractice claims increased by more than 250% during the past seven years when compared to the seven years before. Between 2006 and 2013, there were 16 events, and between 2014 and 2021, there were 45 incidences, totaling 61 incidents throughout 25 states. In the medical-legal world, especially amid the rise in medical malpractice claims, there is often discussion about robotic surgery and legal liability.

Who is liable for a robotic-assisted surgery error?

In the case of robotic surgery, the surgeon using the tool remains obligated to render the highest level of care, and it is his or her duty to operate the instrument properly. When there is some error in the robotic-assisted surgery, leading to injuries or any other damages, the patient must demonstrate that the risk of a robotic malfunction would have been decreased if the procedure had been carried out at another facility or by another surgeon.

Since every robotic equipment has a likelihood of malfunctioning by nature, this would be difficult to prove on its own. Given the inherent danger and uncertainty associated with robotic surgery, it is especially critical for medical practitioners to exercise every possible caution both before and after the surgical procedure.

However, this does not mean that the medical professional performing the surgery can simply escape from the mishaps resulting from the procedure.

Patients can argue that the manufacturer-provided training for a surgeon was inadequate to effectively use the surgical equipment and carry out the surgery. Unfortunately, there isn’t an established benchmark for how much education a surgeon needs to be licensed to use a robotic surgery system.

da Vinci Robotic Surgery Lawsuits

The da Vinci Surgical System is a robotic surgical system manufactured by the company Intuitive Surgical Inc. The robotic system comprises of four robotic arms. The surgeon controls the arms from an area behind it while maintaining an eye on the process on a screen. The fourth arm is attached to an endoscope so the surgeon gets a look into the body of the patient. Three arms hold equipment to create incisions.

The system utilizes a minimally invasive surgical approach and assists surgeons in minimally invasive surgical procedures. The da Vinci Surgical System was approved by the U.S. Food and Drug Administration (FDA) in 2000. The manufacturer claimed it as a safe and effective option for patients undergoing minimally invasive surgery.

Intuitive Surgical had 6,730 da Vinci Surgical Systems installed as of December 31, 2021, with 4,139 of those systems in the United States, 1,199 in Europe, 1,050 in Asia, and 342 other places.

The below-mentioned are the multiple versions of the da Vinci surgical robotic system

1. The da Vinci SI surgical system
2. The da Vinci X surgical system
3. The da Vinci XI surgical system
4. The da Vinci SP1 surgical system

The da Vinci surgical system’s robot-assisted procedures have resulted in negative outcomes and hardships for many patients. Micro-cracks in the protective covers, which shield some of the robot’s instruments during surgery, such as the case for the scissors attachment, could let electricity escape and cause burn injuries to patients.

The Monopolar Curved Scissors (MDS) or “Hot Shears” of the robot may develop micro-cracks that could enable electrosurgical energy to escape into tissue, according to a 2013 Urgent Medical Device notification that Intuitive Surgical sent to customers.

da vinci robot manufacturer had announced a recall for particular cannulae parts in 2014 due to the possibility that they might incur damage while being used and harm patients undergoing robotic procedures.

A patient’s intestines were allegedly cut in March 2017 during an inguinal hernia repaired with the da Vinci robotic technology. Two days later when the patient left the hospital, this was identified. The patient reappeared with abdominal pain and later passed away that day.

What are the damages caused by the Da Vinci robot?

The following are the damages reported by the patients after undergoing robotic surgery with da Vinci robotic system.

• Burns
• Tears
• Infection
• Organ perforation
• Organ failure
• Internal bleeding
• Death

Thousands of da vinci robot lawsuits have been filed by patients in the United States both in the federal and state courts. As per the da Vinci robot surgery lawsuit,

• Intuitive Surgical has failed to take proper action to correct the problem with its instruments suffering microscopic cracks after just a few uses
• The company has not provided doctors and hospitals with adequate warnings about the potential for patients to suffer burn injuries from robotic surgery.

In 2012, the affected victims made an attempt to consolidate the cases into a multidistrict litigation. The U.S. Judicial Panel on Multidistrict Litigation denied the request stating that the number of claims were not enough to warrant a consolidation.

In April 2014, Intuitive declaimed that they have it set aside $67 million to settle roughly 3,000 claims related to their da Vinci surgical system.

As of March 2018 report of U.S. Securities and Exchange Commission, the company has set aside $17.4 million to settle the da vinci surgical system lawsuits. Majority of the da vinci robot lawsuits are known to settle outside the court confidentially. However, Intuitive Surgical continues to deny any risk of injury associated with their surgical robot system.

In 2021, a 56-year-year male received a $700,000 settlement in a da vinci surgical system lawsuit, after he sued his surgeon for cutting a hepatic duct following a da Vinci assisted gallbladder surgery.

In another intuitive surgical lawsuit, the health systems sued Intuitive Surgical. In two different class action lawsuits, they charge that the company made use of its market power to force clients to sign restrictive repair agreements and pay outrageous prices for replacement parts.

da Vinci Robotic Surgery Lawsuits 2024

A wrongful death lawsuit for Sandra Sultzer, the victim, was filed in Florida during the first week of February 2024.The woman’s small intestine was torn during a colon cancer surgery, according to the lawsuit, and the da Vinci robotic device resulted in severe burns.The small intestine injury caused the patient’s death in February 2022. According to the wrongful death lawsuit, Intuitive Surgical was aware of insulation issues with their robotic system that could result in patients suffering burn injuries. Additionally, it alleges that Intuitive fails to adequately train surgeons on the da Vinci device and  instead sells its robots to hospitals without any prior experience performing robotic surgery.

Future of Robotic Surgery

Undoubtedly, more substantial surgical precision will depend on advancements in robotic assisted surgical procedures in the future: Future developments in precision will likely focus on strengthening these abilities even more, allowing surgeons to execute complex surgeries with more accuracy, while understanding da vinci robotic surgery pros and cons.

Miniaturization is another captivating innovation that might result in the development of more compact robotic surgical gadgets to improvise the quality of robotic assisted surgery. These devices can be put into the body through very small incisions, allowing for surgeries that are minimally invasive with less scarring, quicker recoveries, and less chance of complications.

Algorithms may assist surgeons in real-time decision-making, image analysis, and interpretation of complex data through the use of artificial intelligence (AI). Surgeons could benefit from improved surgical planning, intraoperative guiding, and post-operative analysis through implementing AI into robotic surgical systems.

Future developments might potentially include adding haptic feedback systems to robotic surgical tools so that surgeons may sense the forces used during surgery and improve their tactile perception.

Other cutting-edge technologies, like nanotechnology, 3D printing, and personalized medicine, may interact with surgery performed by robots. These technologies may make it feasible to develop surgical tools, implants, and other medical devices that are tailored to each patient, resulting in more accurate and individualized surgical procedures.

It’s key to bear in mind that while robotic surgery has a bright future, there are still obstacles to be dealt with. These challenges include the high cost of robotic systems, ethical issues, legal constraints, and the need for extensive education of surgeons. However, robotic surgery is anticipated to continue transforming medicine while improving patient care with continuous research and innovation. Pros and cons of da vinci robotic surgery may come to light after such studies.

Visit our Instagram, to get more insights:

 

View this post on Instagram

 

A post shared by MedLegal360.com (@medlegal360)