FDA regulators have released a report on Intuitive Surgical’s da Vinci system, which was based on responses from 11 surgeons who had used the system. The report covers complications, patient recovery times, training concerns, and recent spike in adverse event reports linked to the device. The report suggests that the robot could minimize blood loss, reduce anesthesia time, improve recovery time, while facilitating surgical access and visualization.
The participating physicians had performed between 70 and 600 surgeries with the system. On average, physicians noted that patient recovery times for da Vinci surgical procedures were shorter than those for traditional surgical methods. On top of this, physicians stated that the da Vinci system led to fewer complications than other techniques. However, they acknowledged that receiving proper training in operating the device can be a challenge, making it difficult to ensure safe and effective use of the system.
The surveyed physicians recommended that novice users of the da Vinci system get more time in simulation training and dry lab settings. In addition, the group had several recommendations for Intuitive. These included designing smaller arms and instruments for the system, making more procedural data available for physicians, and the addition of tactile feedback.
The FDA noted that the survey size was limited and warned that it would be premature to draw conclusions from such a small survey.
"No conclusions can be made about how the device functions in the broader clinical environment based on this report alone," noted the report by FDA regulators. "Instead, the report should be considered along with other information that may include adverse event reports, scientific publications, clinical trials, enforcement/compliance information, and other data sources that are part of FDA's monitoring of device performance."
Intuitive Surgical has faced mounting negative publicity concerning the device concerning its safety track record. The company maintains that a close look at the FDA MAUDE database shows that the number of deaths and patient injuries related to the da Vinci system is actually decreasing. In part, the company believes that the higher number of reported events was stoked by recent litigation.
In an FDA report, regulators noted that the increased number of reported issues with the da Vinci system were likely the result of an increase in the number of devices being used. In addition, improved reporting methods and increased publicity from recalls could have led to an uptick in the number of adverse event reports filed.
