Before the creation of robotic surgery systems, an electric arc burning the insides of patients wasn’t something that generally happened. Surgeons didn’t have to worry about charred surgical instruments, and their hands and instruments didn’t freeze or move erratically because of computer system errors during surgery.
But all of these have been reported to the U.S. Food and Drug Administration as adverse events — or instances where something went wrong — associated with the use of the da Vinci Surgical System and other robotic surgical systems.
Risks During Surgery
Reports of complications with da Vinci Surgery are extremely rare, but those that do happen can be quite severe. Manufacturer Intuitive Surgical Inc. warns on its website of potential risks and complications with its devices. These include the loss of a large amount of blood, as well as possible inadvertent cuts, tears, punctures, burns or other injuries to organs, tissues, major blood vessels or nerves.
Intuitive also says complications could involve the loss of a piece of the instrument, such as a needle or other object used during surgery, inside the patient’s body. Also, the patient could be injured because of the position of his or her body during surgery.
FDA Reports Link System to Serious Injuries and Deaths
The FDA has an online database of all reports of problems that have 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, health care facilities, patients and lawyers.
In a study titled “Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data” researcher Homa Alemzadeh and colleagues looked at 14 years of reports to the FDA at a time when 1.75 million robotic procedures were performed.
Between 2000 and 2013, a total of 144 deaths, 1,391 patient injuries and 8,061 device malfunctions were reported with robotic surgery, according to the study published in PLOS One in 2016.
Burnt or broken pieces of instruments fell into the patient in 14.7 percent of the reported cases. Another 10.5 percent of reports involved electrical arcing of instruments, and 8.6 percent involved unintended operation of instruments. System errors and video/imaging problems were reported in 5 percent and 2.6 percent of the cases, respectively.
More complex surgeries such as heart, head and neck procedures had higher numbers of injuries and deaths than surgeries for which robots are used more often, such as gynecological and urological procedures. Surgeons had to wait for the system to restart, or they had to switch to non-robotic techniques or reschedule procedures more than 10 percent of the time.
“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,” the authors wrote. “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.”
According to the FDA database, in five years ending on Aug. 31, 2017, the agency received 30 reports of incidents in which the patient died in connection with surgery using the da Vinci system. The system did not necessarily cause those deaths, but they occurred after or during surgery in which surgeons used the system. During that same time period, the FDA received 282 reports involving patient injury.
During an artery bypass operation in 2008, the robotic system being used displayed the error code No. 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 being pushed into the endoscope, cutting the patient’s right ventricle. The surgeon had to make an incision to open the patient’s chest 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 until two days after the patient had left the hospital. The patient returned suffering from abdominal pain and 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.
In addition, patients have filed lawsuits alleging that 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 July 2008 edition of 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 Non-robotic Surgery
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.”
The study looked at 87,514 women 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.
“Compared with laparoscopic surgery, robotically assisted adnexal surgery is associated with substantially greater costs and a small, but statistically significant, increase in intraoperative complications,” according to the study published in Obstetrics and Gynecology.
However, a 2015 study in JAMA Surgery that compared robotic-assisted versus non-robotic cardiac surgery found significantly fewer complications, shorter hospital stays and fewer deaths for the procedures that involved robots.
Body Position Injuries Among Robotic Surgery Complications
Another contributor to complications during robotic surgery is the placement of the patient’s body during the procedure. 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 a 30- to 40-degree angle.
This tilted position 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.
The American Association of Retired Persons Magazine reported 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.
Prolonged pressure on a particular body part can cause 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.
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.
Please seek the advice of a medical professional before making health care decisions.