Intuitive Surgical Responds to Rise in Medical Device Reports
In response to general inquiries regarding a recent rise in Medical Device Reports (MDR) filed by Intuitive Surgical (NASDAQ: ISRG), the company explained that the noted rise does not reflect a change in product performance but rather a change in MDR reporting practices.
In September 2012, Intuitive Surgical revised its MDR practices, resulting in increased reports of device malfunction MDRs, the vast majority of which were related to instruments and not to systems. None of these device malfunction MDRs involved reportable injuries or deaths. "We self-identified the reporting issue, notified the FDA and revised our practices," said Dave Rosa, Senior Vice President, Emerging Procedures and Technologies, Intuitive Surgical.
MDRs can be found in the FDA's MAUDE database, which is updated by FDA regularly. The most common type of report filed under the company's revised MDR practices involves instrument cable breaks. These cable breaks render the instrument non-functional and require an instrument change, which can be accomplished quickly.
The company also made an administrative change in how MDRs previously reported as adverse events were subcategorized. This change has not increased the total number of adverse event reports. This will result in an increase in events in the "serious injury" subcategory and a corresponding decrease in the "other" subcategory. Total adverse event rates have remained low and in line with historical trends.
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