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

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March 22, 2013 — The U.S. Food and Drug Administration (FDA) has received 4,600 reports of side effects, injuries, deaths and adverse events associated with the Da Vinci Robotic Surgery System, according to this investigation conducted by Citron Research. The reports include harmless mechanical malfunctions and also severe, life-threatening injuries and deaths.

Intuitive Surgical has sold Da Vinci Systems since 2000. They are now used at hundreds of hospitals, primarily for hysterectomies and prostatectomies. The use of the Da Vinci has skyrocketed since 2007. In 2010, nearly 10% of all hysterectomies were performed with a robot. Likewise, over 82% of adverse event reports were submitted between 2007 and 2012, and of these, more than 90% were submitted by Intuitive.

Some of these reports involve grievous injuries and deaths. Of the 89 reports of deaths, one death that occurred in August 2010 was associated with a mechanical malfunction that caused a burn to a patient’s artery. According to the report, during a routine hysterectomy:

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

Citron Research highlighted this adverse event and Intuitive’s response: “Based on the limited information provided, it is indeterminable if the Da Vinci System, instruments or accessories contributed to the patient’s demise.”

Citron argues that the comments inserted in the report “show a pattern of the company’s attempt to exonerate itself from liability at every opportunity.”

This lack of culpability is concerning, because many of the injuries were very serious. Citron found that the most common serious injuries were perforations (organ punctures), lacerations (cuts), and tears. This report, for example, involved a patient who suffered grievous injuries after undergoing robotic surgery to remove a small kidney tumor:

“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.”

Although it is not always clear whether the injuries were caused by the Da Vinci, other injury reports involved burns and electrocutions — injuries that are unique to robotic surgery. These serious injuries can be caused by doctor error — especially when doctors are not adequately trained to use the Da Vinci. According to this study published in 2012 by Obstetrics and Gynecology:

“Unintended electrosurgical arcs can occur from monopolar instruments. Insulation failure is a common finding in this type of injury.”

Although no injuries occurred in the majority of the 4,600 adverse event reports identified by Citron Research, many of the reports are concerning because they involve serious injuries or deaths. In some cases, injuries occurred during routine procedures that normally have a low risk of complications.

Recent studies have indicated that the Da Vinci does not provide better patient outcomes for most procedures, but it is substantially more expensive (about $2,200 more expensive for a robotic hysterectomy) and it carries unique risks in addition to the normal risks of surgery (like mechanical malfunction, burns, electrocutions, and surgery error due to inadequate training). Our lawyers are concerned that patients were not fully informed of these risks.

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