FDA has 4,600 Side Effect Reports for Da Vinci Surgical Robot

March 22, 2013 — Citron Research, an independent think-tank group led by Andrew Left, has identified 4,600 adverse event reports associated with the Da Vinci Robotic Surgery System in the U.S. Food and Drug Administration (FDA) database, according to this report. These reports involve everything from minor mechanical malfunctions to life-threatening injuries and deaths.

Although the Da Vinci has been in use since 2000, 82% of adverse event reports were submitted between 2007 and 2012, and over 90% of the reports were submitted by Intuitive Surgical, the manufacturer of the Da Vinci System.

There are 89 reports of death, some of which are “clearly incidental,” while others were clearly associated with the Da Vinci System. For example, this report of a death that occurred on August 12, 2010 involved a woman who died after a robotic hysterectomy when the Da Vinci burned a major abdominal artery:

“The patient had sustained a burn to the right external iliac artery, pumping blood in the body cavity, causing bowel ischemia incompatible with life.”

After an autopsy was performed, Intuitive Surgical wrote the report and concluded: “Based on the limited information provided, it is indeterminable if the Da Vinci System, instruments or accessories contributed to the patient’s demise.”

Citron Research suggests that Intuitive Surgical, which wrote most of the adverse event reports, inserted comments in each report that “show a pattern of the company’s attempt to exonerate itself from liability at every opportunity.” Many of the adverse events were submitted several years after the incident occurred. Even when problems with the Da Vinci appear to have been involved in the incident, the official cause of the injury is usually “undetermined.”

This is concerning, because the second most-common injuries were burns and electrocutions that appear to be caused either by doctor error (electricity is delivered unintentionally or to the wrong tissues) or machine malfunction (insulation flaws in equipment). The report also found that the most common injuries involve perforations (organ punctures), lacerations (cuts), and tears. In this report, for example, a patient suffered severe injuries when surgeons attempted to remove small kidney tumors with the Da Vinci:

“The patient sustained cuts and lacerations, causing injury to the aorta, left renal artery, splenic vein and proximal renal vein. It is also alleged that during the surgical procedure the patient sustained perforation of the pancreas.”

These incidents are concerning because recent studies indicate that the Da Vinci does not improve patient outcome for routine hysterectomies or prostatectomies, but it is significantly more expensive. Robotic surgery also carries unique risks in addition to the normal risks of surgery (such as mechanical malfunction, surgeon error due to inadequate training, burns, and electrocutions). Unfortunately, many patients may been unaware of these risks.