Study: Many robotic surgery errors underreported

6310985_sThe number of reported injuries directly linked to robotic surgery errors is rising, according to data collected from the Food and Drug Administration. In 2004, 13.3 adverse events per 100,000 procedures were reported, and this number increased to 50 events per 100,000 procedures in 2012. Many experts believe that the reports only show a small piece of the picture.

FDA warning letter lists noncompliance issues

The company who manufactures the robots reported to the FDA that there were 282 injuries in 2012, which includes 28 fatalities. In 2013, the FDA sent a warning letter to the company stating that the company had not complied with procedures regarding the reporting of injuries and illnesses that were linked to the robot. Patient injury reports include but are not limited to the following:

  • Burns and heat-related damage to vital organs
  • Tears and lacerations to arteries
  • Puncture wounds and tears to intestines and ureters 

The letter also stated that the company promoted the use of the robot for thyroidectomies even though that use was not cleared by the FDA, and that the company was aware of reports and complaints resulting from that surgery.

Experts believe training is inadequate 

Many doctors and medical experts assert that there is a significant lack of adequate training in the use of the robot. Where traditional surgery requires hundreds of surgeries to be considered competent, the manufacturer provides only a two-day training, which it claims is sufficient. This issue has resulted in reports listing the surgeon as the responsible party in some cases rather than the company.

Marketing overlooks patient safety issues

Hospitals report that they have been urged to purchase the equipment and market it aggressively without informing patients of the risks associated with surgeries. In addition, experts believe that many procedures performed, such as hysterectomies, are more cost-effective and safer if done with traditional laproscopic surgery. One patient undergoing a robotic hysterectomy experienced a laceration to an artery that caused severe bleeding and resulted in her death 13 days later. A large percentage of the injuries and fatalities reported are connected to hysterectomies.

Additionally, some machine malfunctions do not result in injury every time and so are not addressed. Many surgeons have related instances where the robotic arm jerked or failed during a procedure, cables broke, and pincers locked up around tissue and would not release until the robot was shut down. In most of these cases, surgeons completed the surgery using traditional practices, but the danger for medical errors in future cases remains.

Because an injury from a robotic surgery may stem from a manufacturing defect, an undertrained surgeon, a common medical error or another source, legal counsel is advisable for victims and their families.