Adverse Effects of da Vinci Surgical Systems on the Rise, May be Inadequately Reported

The da Vinci Surgical System has seen increased use in a number of common operations in Kentucky, Indiana and across the United States since its clearance by the Food and Drug Administration (FDA) in 2000. These robot-assisted surgical devices have also been linked to a growing number of complications, the actual amount of which may be underreported.

In November, the Public Broadcasting Service (PBS) program NewsHour aired a piece about a study that found complications and deaths caused by surgical robots were going underreported to the FDA. That study—published in the Journal for Healthcare Quality—detailed multiple circumstances in which potential adverse effects of the da Vinci Surgical System were not adequately reported to the FDA. The research unveiled at least five instances in which possible complications linked to a da Vinci surgical robot were not reported to the FDA at all.

Even with the possibility of unreported complications, adverse effect reports linked to da Vinci Surgical System and made to the FDA have doubled over the past year. The Bloomberg News article “Intuitive Surgical Robot Incident Reports Double in Year” states that there were 1,595 adverse incident reports associated with da Vinci surgical robots in 2012 compared with 3,697 reports so far this year. The da Vinci Surgical System is produced and marketed by Intuitive Surgical, which faces mounting lawsuits over complications—including deaths—linked to the robot-assisted instruments.

The Bloomberg News feature indicates that many of the reports to the FDA are as yet unverified, but it also focuses on a physician survey that suggests “no consistent training exists” for the use of da Vinci robot systems. Earlier this year, the FDA sent Intuitive Surgical a warning letter after the agency found that adverse effects and device corrections had not been properly reported.