FDA Warns About Da Vinci Robot Warnings The Company Never Shared

CNBC News is reporting that Intuitive Surgical, the maker of the Da Vinci Surgical Robot - currently facing numerous lawsuits and allegations that the device can harm patients – has received a 483 letter from the Food and Drug Administration warning of possible federal regulation violations. The letter, a notification that a potential violation has been identified, allows the company a chance to respond and defend the action in question.

The FDA believes Intuitive Surgical was revealing a device error without contacting the FDA first and foremost.

In this instance, the letter has been sent over FDA concerns that Intuitive Surgical reported a problem in the device to surgeons and hospitals without first informing the regulator. Federal rules stipulate that any known issues or suspected problems must be reported to the FDA. In warning doctors about a problem with “arcing” – whereby an electric shock can accidentally strike patients – and suggesting ways of dealing with it, the FDA believes Intuitive Surgical was revealing a device error without contacting the FDA first and foremost.

As 483 letters allow for a rebuttal, Surgical Intuitive has responded to the allegations. The warnings and advice, they say, were reiterations of existing labeling directions, did not require a new label change, and so were not a reportable action. As current labels were already approved by the FDA, the company believes that its letter is exempt from mandatory reporting rules as it has no impact upon the labels or product.

The FDA is now investigating these claims before deciding whether further action is required.

A number of lawsuits have been filed against Intuitive Surgical after it was alleged that device defects could potentially harm patients. The company was also accused of aggressively marketing Da Vinci Robots to hospitals, and providing inadequate training to surgeons who would be using the device.