Intuitive Surgical Comments on Medical Device Reporting Practices
SUNNYVALE, Calif., March 13, 2013 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc.
In response to general inquiries regarding a recent rise in Medical Device
Reports (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, 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
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
About Intuitive Surgical's Products
Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale,
California, is the global technology leader in robotic-assisted, minimally
invasive surgery. Intuitive Surgical develops, manufactures and markets
robotic technologies designed to improve clinical outcomes and help patients
return more quickly to active and productive lives. Intuitive Surgical's
mission is to extend the benefits of minimally invasive surgery to the
broadest possible base of patients. Intuitive Surgical — Taking surgery beyond
the limits of the human hand™.
About theda Vinci^®Surgical System
Theda Vinci^®Surgical System is a breakthrough surgical platform designed to
enable complex surgery using a minimally invasive approach. Theda
Vinci^®Surgical System consists of an ergonomic surgeon console or consoles,
a patient-side cart with three or four interactive robotic arms, a
high-performance vision system and proprietaryEndoWrist^®instruments.
Powered by state-of-the-art robotic and computer technology, theda
Vinci^®Surgical System is designed to scale, filter and seamlessly translate
the surgeon's hand movements into more precise movements of
theEndoWrist^®instruments. The net result is an intuitive interface with
breakthrough surgical capabilities. By providing surgeons with superior
visualization, enhanced dexterity, greater precision and ergonomic comfort,
theda Vinci^®Surgical System makes it possible for more surgeons to perform
minimally invasive procedures involving complex dissection or reconstruction.
This ultimately has the potential to raise the standard of care for complex
surgeries, translating into numerous potential patient benefits, including
less pain, a shorter recovery and quicker return to normal daily activities.
For more information about clinical evidence related to da Vinci Surgery,
please visit www.intuitivesurgical.com/company/clinical-evidence/
Intuitive^®, Intuitive Surgical^®,da Vinci^®,da Vinci S^®,da Vinci^®S HD
Surgical System,da Vinci^®Si,da Vinci^®Si-e^TMSurgical
andInSite^®are trademarks or registered trademarks of Intuitive Surgical,
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
regarding our medical device reporting practices, related device malfunction
filings, product performance and the speed at which instrument changes can be
accomplished. These forward-looking statements are necessarily estimates
reflecting the best judgment of our management and involve a number of risks
and uncertainties that could cause actual results to differ materially from
those suggested by the forward-looking statements. These forward-looking
statements should, therefore, be considered in light of various important
factors, including the following: the impact of global and regional economic
and credit market conditions on health care spending; health care reform
legislation in the United States and its implications on hospital spending,
reimbursement and fees which will be levied on certain medical device
revenues; timing and success of product development and market acceptance of
developed products; procedure counts; regulatory approvals, clearances and
restrictions; guidelines and recommendations in the health care and patient
communities; intellectual property positions and litigation; competition in
the medical device industry and in the specific markets of surgery in which we
operate; unanticipated manufacturing disruptions or the inability to meet
demand for products; the results of legal proceedings to which we are or may
become a party; our ability to expand into foreign markets; and other risk
factors under the heading "Risk Factors"' in our report on Form 10-K for the
year ended December31, 2012, as updated from time to time by our quarterly
reports on Form 10-Q and our other filings with the Securities and Exchange
Commission. Statements using words such as "estimates," "projects,"
"believes," "anticipates," "plans," "expects," "intends," "may," "will,"
"could," "should," "would," "targeted" and similar words and expressions are
intended to identify forward-looking statements. You are cautioned not to
place undue reliance on these forward-looking statements, which speak only as
of the date of this press release. We undertake no obligation to publicly
update or release any revisions to these forward-looking statements to reflect
events or circumstances after the date of this press release or to reflect the
occurrence of unanticipated events.
CONTACT: Investor Relations
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