Additional Violations of Intuitive while already in the midst of Crisis

Negative press release, denial of insurance firms to cover robotic surgeries, increase in the number of lawsuits and decrease in demand have all resulted to a quite significant drop in Intuitive Surgical Inc.’s projected shares and sales for 2013.

But probably worse than all those stipulated above is the US Food and Drug Administration’s July 16, 2013, warning letter to Intuitive, due to the latter’s failure to inform the FDA about the communication it sent only to a few medical providers. This warning, which the FDA declared was due to Intuitive’s violation of a federal rule, comes in the midst of lawsuits and product recall that the company is facing.

A number of the violations Intuitive is guilty of include failure of Intuitive to notify the FDA regarding:

  • The robot’s damaged tips, which could definitely injure patients
  • Problems during thyroid surgeries (worse, da Vinci has no clearance to perform this type of surgery)
  • Concerns on the proper flushing and inspection of cannulas
  • Use of the device in surgeries involving children

These issues stem from accusations that the company’s da Vinci surgical robot is dangerous. In the hands of improperly trained surgeons, errors can lead to lifestyle changing injuries in patients who were expecting minimally-invasive procedures with quick recovery times. On top of the challenges Intuitive is facing from the FDA, it is also facing many surgical robot lawsuits.