Biomedical Engineer Comments on Robotic Surgery System

I have been following the IS/daVinci saga for over 5 years with interest, as the multiple issues and alleged failures directly match up with my specific areas of expertise (electrical engineering/biophysics, software engineering, quality engineering & FDA regulations, and human factors/ergonomic engineering). I am also familiar with their FDA recalls, including the most recent ones just this year. I am working with a firm on the shareholder suit against Intuitive. I have worked as an expert witness on a number of medical device product liability cases, including very large MDLs, grouped cases in State courts, and individual plaintiffs’ claims. I am familiar with (and have been following for the past few years) the public domain descriptions and allegations that IS labeling and training procedures violate multiple basic principles of human factors engineering and FDA regulations, as well as trying to shift the burden of training proficiency to the hospitals. As I have recently published, medical manufacturers can deem risks acceptable, but they can only accept those risks for themselves, not others (such as hospitals, providers, and patients).