September 5, 2013 — In the Journal for Healthcare Quality, researchers from Johns Hopkins University have published a study investigating a suspiciously low number of adverse event reports involving the Da Vinci Surgical Robot. Although other studies suggest that complication rates for robotic surgery are similar to traditional surgery, under-reporting of adverse events could be hiding an increased risk.
Since 2000, approximately 1 million surgeries have been performed with the Da Vinci Surgical Robot. However, the FDA has received reports of only 245 adverse events, including 71 deaths. Gynecological procedures were associated with 22 deaths, and hysterectomies accounted for 43% of injuries (mostly involving bleeding).
These numbers are very low for a complex medical technology. Several incidents were reported many years after the incident occurred, and some were only reported to the FDA after making national headlines.
According to Dr. Martin Makary, lead researcher on the study:
“Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”
Researchers attributed the under-reporting of adverse events to problems with a lack of standardization and clarity. For example, surgeons who made mistakes might not report a user error because the FDA does not track these events. The researchers argued that these events should be reported because user errors are more common in robot surgery than in traditional surgery.
In July 2013, the FDA sent a warning letter to Intuitive Surgical regarding deficiencies in the company’s handling of complaints. Inspectors also found that the company did not properly recall defective scissors, which could electrocute and burn patients during surgery.
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