September 26, 2020

The Niche

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Intuitive Surgical (ISRG) Gets Problematic FDA Inspection Report

I have some interest in robotic surgery.

About three and a half years ago I had surgery for prostate cancer and my surgeon used the da Vinci robotic surgery device made by Intuitive Surgical Inc (ISRG).

At the time, da Vinci seemed new and exciting, but the device and the company have become more well-known since then. Not surprisingly, the company has faced challenges as it evolved.

Intuitive Surgical (ISRG)

Today, Intuitive fell short of Wall Street expectations for the 2nd quarter and its stock plunged about 12% after hours.

Sure to add salt to the wound, Wall Street traders were very downbeat even without seeming aware of another development that isn’t exactly good news for the company.

Intuitive was recently inspected by the FDA, which issued a 483 inspection report containing four critical “observations” of problematic issues with the company’s actions.

You can read that FDA report here.

Reportedly, the company became aware of certain problems with or limitations of their da Vinci device and sent out letters to “clients” (which by the way are doctors and health systems, not the patients for whom the devices are used such as me) about the issues that in some cases caused patient injuries, but messed up by not informing the FDA of the problems.

Basically they did not report adverse events, which is a serious mistake.

Some of the company’s actions may also have put children at risk as the FDA notes:

…the vagueness in the previous version of the IFU represented a health risk to pediatric patients.

I don’t think this is a major blow to ISRG, but it certainly doesn’t come at a good time and suggests some serious issues that need resolution in terms of company compliance procedures to ensure patient safety.

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