New FDA Report on da Vinci Surgical System Highlights Need For Heightened Surgeon Training, Reports Audet and Partners, LLP

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A new FDA Report surveying da Vinci Robot surgeons suggests need for increased training of surgeons prior to deployment on human patients.

Mirena IUD Lawsuit and Legal Information

William M. Audet, J.D., L.L.M.

The nature of the da Vinci Surgical System is fundamentally different from techniques and procedures taught in medical school. The skills necessary for safe deployment must be acquired by surgeons through extensive training.

The U.S. Food and Drug Administration (“FDA”), has issued a Final Report of findings gathered through a survey of surgeons throughout the United States who have used the da Vinci Surgical Robot in various medical procedures. The survey was conducted by the FDA, “to better understand [surgeon] perspectives on the different challenges raised when using the system interface to perform surgery versus using conventional surgical procedures.” *

In receiving survey responses from eleven da Vinci robot surgeons, most from hospitals with a bed size of 100 or more, the FDA Report highlighted the following suggestions:

(1)    All survey respondents reported a need to perform multiple surgeries before feeling fully proficient in using the da Vinci surgical system;

(2)    That additional dry lab testing be offered and/or provided; and

(3)    That pre-surgery training consist of a mandated threshold of hours.

While the FDA’s investigation into design problems continues, the FDA’s Report suggests that inconsistent surgeon training, or lack thereof, may be another problem in causing patient injuries. Jeff Berkley, chief executive of Mimic Technologies Inc., which makes robotic surgery simulators for training purposes, told Bloomberg, “[t]raining for robotics has been the wild, wild west for a long time,” and that hospitals and doctors realize, “they have to get their act together and start focusing on training.” **

William Audet, whose law firm Audet and Partners, LLP represents several individuals in law suits alleging serious personal injuries resulting from da Vinci surgery, applauds the FDA Report for light shed on the need for increased training of surgeons in this nascent technology. “The nature of the da Vinci Surgical System is fundamentally different from techniques and procedures taught in medical school. The skills necessary for safe deployment must be acquired by surgeons through extensive training. In the absence of such training, humans should not be placed at risk by procedures, the benefit of which have been called into question by numerous lawsuits.”

If you, or one you know, has suffered serious personal injuries that may have resulted from robotic surgery using the da Vinci Surgical System, you are urged to contact a da Vinci lawyer at Audet and Partners, LLP by calling (800) 965-1461. To learn more about pending da Vinci robot lawsuits, you can visit http://www.davinci-surgical-robot-lawsuit.com.

*http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/ComputerAssistedRoboticSurgicalSystems/UCM374095.pdf

** http://www.bloomberg.com/news/2013-11-11/robot-surgery-incidents-may-pressure-hospital-training.html

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William Audet, J.D., L.L.M.
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