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FDA Reports of Da Vinci Surgical Robot Malfunctions, Injuries

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March 21, 2013 — The U.S. Food and Drug Administration (FDA) has received thousands of reports of the Da Vinci Surgical Robot malfunctioning. Although the majority of of these mechanical problems did not affect surgical outcomes for the patient, there are reports of patient injuries from malfunctions. According to Intuitive Surgical, the company that manufactures the Da Vinci Surgical Robot, the most common malfunctions “involve instrument cable breaks.” Unfortunately, other reports include patient injuries, organ damage, blood vessel perforation, and more.

An investigation conducted by CNBC in March 2013 accessed public adverse event report data from the FDA through a Freedom of Information Act (FOIA) request. Reports of malfunctions of the Da Vinci Surgical System included:

  • December 13 — “It was reported … the da Vinci system hit the patient in the face. It was unknown if the patient was injured … The surgeon made the devision to convert the procedure to traditional open surgical techniques to complete the procedure.”
  • December 28 — During a hysterectomy, “the bipolar instrument fired unintentionally during a procedure. … The instrument tip did touch the patient’s uterus.” However, the doctor successfully completed the procedure.
  • January 2 — During a hysterectomy, “the arm jumped, causing the instrument … to stab an artery, which led to some bleeding that the surgeon was able to control without converting the procedure.”
  • January 4 — During a hysterectomy, “the patient’s ureter was damaged. During repair of the patient’s ureter by the site’s urologist, the urologist noted that the jaw on the EndoWrist instrument installed on the patient side manipulator was not articulating correctly.” The surgeons completed the hysterectomy using open surgical techniques.

These reports indicate that the Da Vinci Surgical Robot can malfunction and injure a patient or complicate a surgical procedure. The rate of malfunctions is unknown, but studies of surgical robot malfunctions have estimated the risk to be anywhere from 0.4% to 2.5% of all procedures. The risk likely depends on the institution where the procedure is performed, how many procedures are performed there, and the experience level of the surgeon using the surgical robot.

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