Intuitive's da Vinci Surgical System Faces Mounting Troubles

Qmed Staff

September 6, 2013

3 Min Read
Intuitive's da Vinci Surgical System Faces Mounting Troubles

The da Vinci robotic surgical system by Intuitive Surgical may face even more problems than originally thought, according to new research published in the Journal for Healthcare Quality, "We're not learning from our performance," noted Dr. Martin Makary, a study coauthor.

From January 1st of 2000 to August 1st of 2012, FDA regulators received 245 reports of adverse events associated with the use of the da Vinci robotic surgical system. However, the total number of adverse events associated with the system appears to be even higher than that.

In the study, Dr. Makary and his colleagues discovered that there were an additional five cases that weren't reported to FDA regulators. On top of this, three of the cases that were reported to FDA regulators were questionable. In one case, a study was submitted 292 days after the adverse event took place. In another case, the adverse event report wasn't submitted for almost three years. In another case, FDA regulators only took note following a news story on the death of a patient.

In total, Dr. Makary's team uncovered eight adverse events (including five that were not submitted to FDA regulators). According to him, this comprises only a small sampling of an unknown, larger number of misreported or unreported adverse events associated with the da Vinci surgical system.

"We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there," noted Dr. Makary.Dr. Makary also stated that the total number of reported cases "seems very low, given the discussion of these events in the surgical community."For its part, Intuitive Surgical didn't respond to press inquiries on the study. However, filings with the United States Securities and Exchange Commission indicate that the company believes its technology is "safe and effective." With its computerized da Vinci system, physicians can perform laparoscopic operations through the use of robotic arms. The system gives physicians a 3-D view of a procedure site, similar to an open surgery.The da Vinci system first received approval from FDA regulators in 2000. Since that time, use of the system has grown exponentially. Last year, 367,000 procedures in the United States were performed with the da Vinci system. In comparison, 292,000 procedures were performed with the da Vinci system in 2011. In total, approximately four-fifths of procedures were urologic or gynecologic. In particular, prostatectomies and hysterectomies led the way as the most common procedure. As of late June, there are approximately 2000 da Vinci systems in use in the United States.In early 2013, FDA regulators began a survey of physicians who utilized the da Vinci system. In the survey, physicians were questioned about the benefits and disadvantages of the system. In it, FDA regulators noted a 34% increase in adverse event reports associated with the da Vinci system. While the spike took place from 2011 to 2012, adoption rates increased only 26%. This indicates that adverse events are leading usage rates by a significant margin.

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