da Vinci Robotic Surgery Complications

New technology brings new possibilities and also new troubles. That’s as true with medical devices as with anything else. And while any surgical procedure carries inherent risks, there are some risks specific to surgery with robots.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

Before the creation of robotic surgery systems, electric arcing burning the insides of patients wasn’t something that generally happened. The surgeon, as a rule, didn’t have to worry about charred surgical instruments, and his hands and instruments weren’t frozen or made to move erratically by computer system errors during surgery.

But all of these have been reported to the U.S. Food and Drug Administration as so-called adverse events, or instances where something went wrong, associated with the use of the da Vinci and other robotic surgical systems.

As the authors of a 2016 study put it, “Despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced during procedures. Adoption of advanced techniques in design and operation of robotic surgical systems and enhanced mechanisms for adverse event reporting may reduce these preventable incidents in the future.”

Fact

More than 8,000 robotic-surgery malfunctions were reported to the FDA during a 14-year-period.

That study looked at 14 years of reports to the FDA at a time when 1.75 million robotic procedures were performed. During that time, 144 deaths were reported and 1,391 patients were injured during robotic surgery. There were more than 8,000 device malfunctions reported to the FDA.

The manufacturer warns that possible risks of robotic surgery include the loss of a large amount of blood, as well as possible inadvertent cuts, tears, punctures, burns or other injuries to organs and tissues, including major blood vessels, organs, ureter and nerves. The manufacturer also says complications could involve the loss of a piece of the instrument, a needle or other object used during surgery inside the patient’s body. Also, the patient could be injured because of the position his or her body is placed in during surgery.

Mechanical Problem Reports to the FDA

The FDA has an online database of all reports of problems that occurred with regulated medical devices. The Manufacturer and User Device Experience, or MAUDE, includes thousands of incidents related to the use of various da Vinci robotic systems, ranging from error code bugs to patient deaths. The reports are filed by manufacturers, healthcare facilities, patients and lawyers.

Examples of adverse events reported to the FDA

Emergency Tracheostomy

During an artery bypass operation in 2008, the robotic system being used displayed the error code #23. Medical personnel powered down the system to clear the error, and then continued with the procedure. The error displayed again. The surgeon disabled the endoscopic camera manipulator and tried to manually move the camera and endoscope for about five or six hours. Then there was a loss of the carbon dioxide that had been used to inflate the surgical area. This resulted in the patient’s heart twice pushing into the endoscope, cutting the patient’s right ventricle. The surgeon then cut the patient’s chest open to manually stitch the ventricle and finish the procedure. At the end of the 14-hour operation, the patient required a tracheostomy because he couldn’t have his breathing tube removed.

Patient with Nicked Intestines Dies

In March 2017, a patient’s intestines were reported to have been nicked during an inguinal hernia repair using the da Vinci robotic system. This was not discovered two until days after the patient had left the hospital. The patient returned suffering from abdominal pain. The patient died that day.

Woman Dies after Organ Removal

In April 2017, a patient underwent a gastric sleeve weight-loss surgery, along with a hiatal hernia repair using the robotic surgical system. Following the surgery, the patient experienced blood loss and was readmitted to the hospital two weeks after the operation. She had part of her stomach and bowel removed. The patient later died at another facility. It’s unclear why the second operation was performed and the surgeon reported no complications during the first surgical procedure.

Energy Release Burns Patient

In December 2016, a patient was undergoing a hysterectomy and having her ovaries removed. Medical personnel reported that the robotic system was not stopping and was cutting too much tissue. Energy traveled during the procedure, burning the fallopian tube and sigmoid colon. The surgeon sutured the colon to stop a leak that had developed. Medical personnel reported a “large distance” between the location of the surgery and the damaged tissue.

Liver Damaged Blamed on Surgeon

In November 2016, during gallbladder-removal surgery, one of the robotic arms reportedly moved on its own, injuring the patient’s liver, causing it to bleed. The surgeon cauterized the injury using the same instrument that had caused the injury. The manufacturer later attributed the incident to user error on the part of the surgeon.

da Vinci System Linked to Deaths

According to the FDA database, in the five years ending on Aug. 31, 2017, there were 30 reports of incidents in which the patient died in connection with surgery using the da Vinci system. Those deaths were not necessarily caused by the system, but occurred after or during surgery in which the system was used. During that same time period, there were 282 reports involving patient injury.

Experts say that the main contributing factors to robotic surgery adverse-event reports are:

30% device failure graphic

30 percent

Device failure

25% device operation/setup graphic

25 percent

Device operation/setup

20% user error graphic

20 percent

User error


11% other graphic

11 percent

Other

7% inadequate training graphic

7 percent

Inadequate training

7% maintenance issues graphic

7 percent

Maintenance issues

In addition, patients have filed lawsuits alleging they suffered injuries such as spleen and liver punctures during heart surgery, rectal damage during a prostate operation and a vaginal hernia during a hysterectomy.

In an incident reported in the Journal of Robotic Surgery, an arm of the robotic system broke during a prostatectomy, requiring the surgeons to cut a larger incision in the patient to remove the piece from inside his body.

Complications Higher Compared to Nonrobotic

A study in 2014 by researchers at Columbia University College of Physicians and Surgeons compared robotic and laparoscopic adnexal surgery. Adnexal surgery is surgery performed on the ovary, fallopian tube or ovarian cysts.


"Compared with laparoscopic surgery, robotically assisted adnexal surgery is associated with substantially greater costs and a small, but statistically significant, increase in intraoperative complications.”

- Study Authors at Columbia University College of Physicians and Surgeons


The study looked at 87,513 patients between 2009 and 2012, a period when robotic surgery on the ovaries increased from 3.5 percent to 15 percent. The study found the overall complication rate was 7.1 percent for robotically assisted surgery, compared with 6 percent for laparoscopic removal of the ovaries.

However, a 2015 study that compared robotic vs nonrobotic cardiac surgery found significantly fewer complications, shorter hospital stays and fewer deaths for the procedures that involved robots.

Body Position Injuries Among Complications During Robotic Surgery

Another contributor to complications during robotic surgery is the position that patients may be placed. Some laparoscopic robotic surgery is performed with the patient in a position called the Trendelenburg, in which the body is tilted with the head closer to the floor and the feet higher up. Routinely, the patient can be positioned at an angle of 30 to 40 degrees.

Body Position Injury

Certain body positioning required for better exposure for the da Vinci surgical device can lead to bruising, nerve damage and other neuromuscular injuries.

The American Association of Retired Persons Magazine reports the case of Paul Elliott, a 55-year-old public high school teacher in California who awoke from having his prostate removed with no feeling in his shoulders and arms. Because he was in the tilted position during the eight-hour, robot-assisted operation, Elliott suffered nerve damage and never regained full use of his left hand.

This positioning provides the best exposure of the pelvis and lower abdomen for robotic surgery. The positioning is required to provide access to the surgical field and accommodate the robotic camera system and arms, particularly with robotic gynecologic surgery.

However, in traditional laparoscopy, a patient can be moved during surgery to compensate for slipping on the table. This is not possible during robotic surgery. The robot can’t compensate for changes in the patient’s location on the operating table.

The positioning can lead to the patient shifting during surgery, causing bruising and other neuromuscular injuries. This shifting can create tears in incisions and the formation of hernias after surgery. It can add to postoperative pain related to the stretching of the abdominal wall.

Patients may also awaken with swelling of their faces and larynx. The position for long periods can also lead to swelling of the brain and increased intracranial pressure.

Compression injuries

A serious possible complication from this type of position is called rhabdomyolysis, which is a serious syndrome that results from the death of muscle fibers and the release of their contents into the bloodstream. This can lead to problems including pain, kidney failure and even death. This can result from a compression injury to the skeletal muscle, which can cause substances such as myoglobin, electrolytes and proteins to be released into the bloodstream.

Along with the gas used to inflate the body cavity, the body positioning can impair the functioning of the lungs during surgery. This can cause elevated levels of carbon dioxide in the blood.

In addition, this position can have an effect on the cardiovascular system, reducing the flow of blood to and from the heart.

Eyes at Risk

The patient’s face, and specifically eyes, can be injured during robotic surgery if the robotic camera system comes in contact with that part of the body. In some instances, the camera system may be just a few centimeters away from the face during surgery.

The position also increases intraocular pressure, and can lead to retinal detachment or a partial loss of vision and complete blindness after lengthy surgery in the steep Trendelenburg position.

Author

Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. At Drugwatch, Elaine has reported about trials over whether talcum powder caused ovarian cancer and allegations that Androgel causes heart problems in patients who use it. She has chronicled the billions of dollars generated for big pharmaceutical companies by certain drugs and efforts to warn consumers about the dangers of specific medical problems. Elaine has received six health literacy certificates for completing courses offered by the Centers for Disease Control and Prevention. She brings more than 20 years of experience covering state and federal court systems, learning the intricacies of criminal and civil law, developing investigative pieces about how the law affects people’s lives and digging through and digesting reams of court records on a daily basis.


Hide Sources

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