FDA’s Sleep-Over At Intuitive Yields Troubling Observations

Just in case you don’t think the FDA keeps on top of the companies under its watchful eye, take a look at the list of observations it made during site visits earlier this year, here. Scroll to the bottom and see twenty five days between April 1st and the end of May on which the agency was present at the facilities of Intuitive Surgical, Inc. Intuitive, manufacturer of the by-now world-famous Da Vinci robotic surgery system has been found wanting in four areas.

Background

The red pen came out for Intuitive Surgical during a series of visits in April and May. As with all things US-regulatory, the transparency of all these goings on is easy meat for those of us interested in the goings-on. At this point, these are only observations, not “final agency determinations” and the company still has the opportunity to put in place the required corrective actions. Nonetheless, watchers of the developing technological area that is robotic surgery will no doubt be interested in what the FDA found during their frequent visits.

First up, the company instigated four “field actions” without telling the agency. They can all be found in the report, but include things like sending out modified instructions to users and sending out communications that are too vague to avoid potential risk to patients. All should have been notified to the local FDA coordinator.

Next, the company failed to report five incidents concerning illness or injury related to the device, to the local office of the FDA.

Then they added the thyroid indication to their laparoscopy indication without documenting how the decision was made not to submit a new 510(k) submission. This despite the fact that Intuitive does seemingly have a procedure for making this decision.

Finally, and this one looks super picky, the inspection revealed that the company had failed in its documentation of design input requirements. Seemingly it has been observed that some surgeons will wipe instruments clean intrasurgically by scraping them across other instruments. This has been known to cause arcing, with potential and actual risk to patients. The issue then is that the design input folks didn’t spot the potential for surgeons to do this. Either that or they didn’t document it correctly.

Intuitive now awaits the full warning letter.

Getting a flavour of life in the regulatory department at a U.S. medical device company?

Source: FDA, Fierce Medical Devices