FDA Reports of Da Vinci Surgical Robot Injuries

March 20, 2013 — Ever since Intuitive Surgical received approval for the Da Vinci Surgical Robot in 2000, a growing number of people have reported serious adverse events to the U.S. Food and Drug Administration (FDA).

Although Intuitive Surgical recently admitted that the most common malfunctions “involve instrument cable breaks,” the FDA has also received adverse events involving organ damage, blood vessel perforation, and more.

According to this CNBC investigation of adverse event reports submitted to the FDA:

• December 13 — : “It was reported … the da Vinci system hit the patient in the face.” Although it was unknown if the patient was injured, the surgeon decided to complete the procedure using open surgical techniques.
• 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 — “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 arm was not articulating correctly.” The surgeons decided to finish the procedure using open surgical techniques.
• December 28 — During a hysterectomy, “the bipolar instrument fired unintentionally during a procedure. … The instrument tip did touch the patient’s uterus.”

These reports indicate that patients can occasionally be injured when the Da Vinci Surgical Robot malfunctions. Although researchers have attempted to determine how frequently malfunctions occur, estimates range from 0.4% of all procedure to as high as 5%. The risk likely varies depending on the institution, the number of procedures performed at that institution, and the experience level of the surgeon performing the procedure.