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News Breaks | | | | March 14, 2013 | | 05:07 EDT |  | ISRG | Intuitive Surgical explains rise in MDR is result of reporting practices
In response to general inquiries regarding a recent rise in Medical Device Reports, or MDR, filed by Intuitive Surgical, 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. 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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News For ISRG From The Last 14 Days Check below for free stories on ISRG the last two weeks. |
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| May 14, 2013 | | 17:48 EDT | | ISRG | Lone Pine gives quarterly update on stakes
NEW STAKES: Valeant Pharmaceuticals (VRX), Virgin Media (VMED), Thermo Fisher Scientific (TMO), CME Group (CME), and Liberty Media (LMCA). INCREASED STAKES: Mead Johnson Nutrition (MJN), News Corp (NWSA), Intuitive Surgical (ISRG), Monsanto (MON), and Qualcomm (QCOM). DECREASED STAKES: Cognizant Technology Solutions (CTSH), Equinix (EQIX), Ralph Lauren (RL), Disney (DIS), and Oceaneering International (OII). LIQUIDATED STAKES: Facebook (FB), Crown Castle (CCI), Accretive Health (AH), Informatica (INFA), and NetEase (NTES). | | | May 10, 2013 | | 12:56 EDT | | ISRG | Intuitive Surgical drops after identifying defect in robot tool
 Subscribe for More Information | | | 09:21 EDT |  | ISRG | Intuitive Surgical volatility flat
Subscribe for More Information | | | 09:10 EDT |  | ISRG | Intuitive Surgical warns on 'potential issue' with instrument, CNBC says
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