FDA Notes Increase in Reports Involving Surgical Robot Injuries, Problems

Reports of complications, injuries and death following robotic surgery are increasing, according to federal health experts who have released new recommendations for surgeons and called for more robot surgery training.  

On November 8, the FDA updated its webpage on computer-assisted robotic surgery and released the results of a survey (PDF) sent to surgeons involving the use of Intuitive Surgical’s da Vinci Surgical System.

The agency indicates that it is aware of an increasing number of adverse events submitted involving robotic surgery, including problems with the surgical robot and reports involving serious injury and death for patients.

According to a report by the Wall Street Journal, there is a draft analysis of the da Vinci robot by Jai Raman, the chief of adult cardiac surgery at Rush University Medical Center, which found that surgical robots have been linked to an increasing number of surgical complications since 2004. Raman reportedly looked at 4,798 robotic surgery adverse event reports, including at least 85 deaths, 414 injuries and 3,402 cases of robot malfunctions.

The FDA’s latest recommendations seem to mirror some of those findings.

“The majority of the medical device reports the FDA received were of device malfunctions, such as component breakage, mechanical problems and image/display issues,” the FDA notes. “However, the FDA has also received reports of injuries and deaths related to the device.”

The increase in da Vinci incident complaints was first reported by an independent investment analysis firm, Citron Research, which issued a report on October 3 that warned investors about the impact these incidents may have on the stock price for Intuitive Surgical, the manufacturer of the da Vinci robot.

Citron reported that over the first eight months of 2013, more than 2,332 da Vinci robotic surgery complaints were reported to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database. This compares with 4,603 reports received for the 12 year period between 2000 and 2012.

Reports highlighted by the investment research firm included cases of bowel perforations, serious injuries and deaths, with many of the cases appearing to be years old and only surfacing now because of an increasing number of da Vinci surgical robot lawsuits filed against Intuitive Surgical.

The da Vinci Surgical System is used for number of different urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The surgical robot has been aggressively promoted in advertisements directed to consumers, promoting the device as a superior alternative to traditional surgery because it is less-invasive and results in reduced recovery time.

As Intuitive Surgical’s $1.5 million robot has been used with increasing frequency at hospitals throughout the United States in recent years, a growing number of reports have surfaced involving individuals experiencing problems following robotic surgery that are caused by burns, tears and other internal injuries. Concerns have also surfaced about whether the robot is over-used and whether it provides sufficient benefits over traditional procedures in many different applications.

Survey Finds Training Inconsistencies

Earlier this year, in response to concerns about the safety of the da Vinci robot, the FDA sent a survey to surgeons to obtain their perspectives on challenges raised when using the surgical system

The agency released the final report from a small sample surgery this month. In responses submitted by 11 surgeons who used the da Vinci Surgical System, all reported needing to perform multiple surgeries before they felt fully proficient at using a surgical robot. However, they also said that it was not too complex for surgeons to learn. Those with experience conducting laparoscopic surgeries appeared to have an easier time learning to use the robot. However, training varied greatly from surgeon to surgeon. Some hospitals have instituted robot surgery credentialing, but not all.

“The training programs and the approach to monitoring surgeons vary among institutions,” according to the survey report. “Some programs are comprehensive, team-focused, and involve close monitoring by proctors. Others depend on the individual surgeons determining what they need to successfully perform procedures using the system. Challenges include getting staff trained and trying to get an efficient process in place to deal with system setup.”

The FDA is now calling for doctors and hospitals using the robot to make certain that proper training is completed and that all surgeons are appropriately credentialed. The agency also calls for users to understand that there are several different models which may function differently and that training should be on each model.

The FDA advices potential patients to be aware that robot surgery may not be appropriate in all situations and urges them to discuss the benefits and risks of robot surgery with their surgeons.