Biomedical Engineer Comments on Robotic Surgery System

This surgical technology case takes place in Colorado and involves a patient who underwent a hysterectomy using a da Vinci Robotic Surgical System. The patient suffered thermal rectal burns and perforation that went unrecognized at the time of the surgery. She subsequently developed a massive infection that required emergency medical intervention, as well as multiple corrective surgeries. As a result of this infection the patient nearly died, and has been left with a range of debilitating injuries that will impact her quality of life indefinitely. It is alleged that the robotic surgery system was negligently designed and/or manufactured, and that such an outcome could have been prevented.

Question(s) For Expert Witness

1. Please describe your experience/knowledge as it pertains to the Da Vinci surgical system, specifically as it relates to patients like the one in this case.

2. Have you ever served as an expert on a similar case? If so, please explain.

3. Are you familiar with the way that Intuitive Surgical sells the Da Vinci system to hospitals and physicians, as well as any training/certification provided to physicians using this system?

Expert Witness Response E-004882

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).