DaVinci Surgical System Poses Unusual Patient Risks for Gynecological Surgeries

The daVinci surgical system has been in the forefront of the national news lately. Manufactured by Intuitive Surgical, the daVinci is a complex robotic system which is

represented as being a way in which various surgeries can be performed in a minimally invasive manner. The company represents that because the surgeries are

“minimally invasive”, there is less scarring, less blood loss, and less surgical recovery time for the patient.

To use the system, the surgeon controls the giant robot from a console. Through small incisions, the tips of the robotic arms are maneuvered from the console to perform

surgery. The device is most often used in hysterectomies and other gynecological procedures, but it can be used for other surgeries, including prostate surgery.

Use of the system is NOT without risk, however.  The FDA’s MAUDE system lists approximately 20,000 adverse events involving the daVinci over the last decade.  The list contains

catastrophic injuries and 274 deaths. In fact, there have been reported injuries to the ureter, colon, and other tissue and body organs. There have been reported injuries to

arterial vessels, causing extensive blood loss.

According to a recent report by NBC News, the daVinci has also had 175 recalls. While some of the recalls were initiated for minor revisions and changes, some were also

required to prevent additional patient injury. Perhaps most unexpected, there have been thermal, or burn injuries reported by doctors and patients. In a 2013 Warning Letter

issued to the manufacturer, the FDA noted problems caused by electrical arcing.  Specifically, it has been reported that electricity arced from the tip of the robotic arm to the

patient’s flesh, causing the patient to suffer burn/ thermal injuries. Certainly, most patients who agree to undergo “minimally invasive” surgery do not expect electrical burn injuries

to tissue or body organs.

While some of the problems with the daVinci are related to the dangers of the device itself, other problems are attributable to lack of surgeon training on the device.  It is reported

that a surgeon’s inadequate training is a leading cause for patient injuries. It might surprise patients to know that there are no training requirements imposed on a surgeon before a surgeon

can use the device. While the manufacturer offers training, it does not require training before the device is sold.  Further, the FDA has stated that it has no authority

to oversee a surgeon’s training or to impose training requirements on a surgeon before the device is used on patients.  

Thus, a patient given the option of surgery with the daVinci system is faced with a daunting choice: either opt for an open procedure with all of the usual risks and down-time of the procedure,

or agree to the robotic technique and trust that the patient’s surgeon has the capability to control the robot without incurring injury.

   

Waymo launches nation’s first commercial self-driving taxi service in Arizona.

The AP (12/5, Liedtke) reports Waymo launched its commercial self-driving taxi service, known as Waymo One, in Arizona Wednesday. At first, the service “will only be available to a couple hundred riders, all of whom had already been participating in a free pilot program that began in April 2017.” The service will also be “confined to a roughly 100-square-mile area in and around Phoenix, including the neighboring cities of Chandler, Tempe, Mesa, and Gilbert.”

        Venture Beat (12/5, Sawers, 55K) reports that the self-driving vehicles “will be available round the clock in the Metro Phoenix area, and it is worth noting here that although the cars are fully self-driving, a ‘driver’ will be present in the car at first.” However, Venture Beat states that “Waymo isn’t really pitching these as ‘safety’ drivers as it doesn’t anticipate their having to step in to take control – it’s more about peace of mind for people apprehensive about stepping inside a driverless vehicle.”

        The Arizona Republic (12/5, Randazzo, 903K) reports that “Waymo doesn’t disclose how many of its Chrysler Pacificas are on the road in Arizona but reports 600 in operation nationally.” The Republic notes that the “company also placed orders for 62,000 more Chryslers and 20,000 Jaguar I-Pace electric vehicles this year that it says will be used to expand the ride service in the coming years.”

        Ars Technica (12/5, Lee, 536K) reports that “passengers will hail vehicles with a Waymo One app, which will be available for both iOS and Android phones.” The apps are similar to the ones developed by Uper and Lyft in that it “prompts the user to enter a pickup location and a destination.” The app also “provides estimates of the cost and likely arrival time before the customer books the ride.”

        According to Ars Technica, “fares are based on time and distance, and customers can expect fares to be roughly on par with what you’d pay for an Uber or Lyft trip --perhaps even a bit lower.” For example, Ars Technica’s Timothy B. Lee said that he punched booked a 4.6-mile trip into the Waymo app and was charged $7.32 for the trip. According to the article, Lee “punched the same route into Lyft and Uber apps on Tuesday afternoon and got quotes of $8.29 and $9.38, respectively.”

        The Washington Post (12/4, Laris, 13.51M) reports Costa Samaras, an automation and infrastructure expert at Carnegie Mellon University, said the move is a “big leap between testing this stuff and booking and transporting a passenger who’s paying money for a service.” Samaras said, “The trajectory of the industry, not just at Waymo, is going to depend on a lot of these early experiences. Do people feel safe? Do people feel comfortable? Is it seamless? ... If it is, we’ll see more of it. If not, people will go back to the engineering room.”

Is your Frontal or Side Impact Really an Auto Products Airbag Case?

When airbags work properly, they are critical to preventing injuries and saving lives; however, an airbag that is improperly designed or manufactured can seriously injure or kill innocent people. Faulty airbags can fail in a number of ways, including if the airbag:

• Hit an occupant before being fully inflated.
• Punched out of its storage compartment and strikes an occupant with excessive force.
• Deployed unnecessarily in a minor accident, causing injury that would not have happened otherwise.
• Ruptured and sprayed shrapnel into the vehicle compartment, like the problem with Takata airbags.
• Failed to deploy.
• Had incorrectly calibrated sensors that caused overly aggressive deployment or no deployment at all.

In airbag cases it is important to evaluate whether the airbag caused or enhanced the injury, such as loss of an eye, blindness, head trauma, shrapnel injury, or failed to deploy and prevent a catastrophic head or spinal cord injury.

Defective Auto Seatbacks and Seatback Strength

I was asked the other day by a friend about where to look to find out about information on the strength of driver’s seatback in a rear impact. The unfortunate reality is, there is precious little information available to the public on the performance and strength of seats in rear impacts, and we see all too often the seatback collapsing in a rear impact causing the person to fly into the rear seat and either strike the person sitting in the rear seat or striking their head and neck on the rear seat causing severe head and spinal cord injuries resulting in death or paraplegia. The average driver or front seat passenger do not expect their seats to collapse in a rear impact.

On average, Americans drive about 46 minutes per day, but rarely do people give a second thought to the quality of the auto seat they sit in for nearly an hour a day, even though their safety depends on it. Unfortunately, when vehicle seats are not structurally sound in their design and build, they become dangerous products that fail at the most critical times and cause catastrophic injuries to occupants.

The seat back mechanism in most passenger vehicles on America’s roads and highways is less structurally sound than a lawn chair you can purchase from a discount retailer.

For more than 30 years, injured people and their families – as well as referring attorneys – have turned to Atlee Hall, LLP for help with catastrophic injury cases involving vehicle seat defects. During that time, we have taken on the world’s largest auto product manufacturers in cases involving a range of auto seat defects, including:

• Seat Back Defects. The seat back mechanism in most passenger vehicles on America’s roads and highways is less structurally sound than a lawn chair you can purchase from a discount retailer. If a seat back collapses backward in a rear-impact crash, the seat occupant and passenger in the seat behind can be seriously injured.
• Seat Track Defects. If the force of a rear impact causes the seat tracks to separate, the seat will collapse backward and throw the occupant toward the rear of the vehicle, likely causing head and neck injuries and harm to anyone sitting in the rear seat.
• Seat Recliner failures. The seat recliner is used to adjust the angle of the seatback, often times using a weak single recliner with teeth on a gear mechanism that spate or strip resulting in the seat collapsing and catapulting the occupant into the rear seat.

Anytime someone has sustained a catastrophic head, spinal cord or fatal injury in a rear impact a close examination of the safety performance of the seat must be evaluated.