Below are Intuitive Surgical statements released to the public.
November 25, 2013
Analysis of Medical Device Reports by Date shows Decline in Overall Adverse Event Rate
Intuitive Surgical publishes an analysis on medical device report (MDR) trends based on the FDA MAUDE database, which shows a decline in overall adverse event rate. Read More
November 19, 2013
Voluntary Recall for Certain Lots of Large Needle Driver and Mega Needle Driver EndoWrist® Instruments
Intuitive Surgical has issued a field notice informing da Vinci Surgical System customers that it is voluntarily initiating a product recall for certain lots of Large Needle Driver and Mega Needle Driver EndoWrist® instruments. Read More
November 19, 2013
Voluntary Product Correction for da Vinci® Patient Side Manipulators (PSMs)
Intuitive Surgical has issued a field notice informing affected da Vinci S, Si, and Si-e System customers that it is voluntarily initiating a correction for the Patient Side Manipulators (PSMs) on the Patient Side Cart and repairing or replacing them as needed. Read More
September 10, 2013
Intuitive Surgical Statement in Response to Journal of Obstetrics & Gynecology, Rosero, et al.
Comparison of Robotic and Laparoscopic Hysterectomy for Benign Gynecologic Disease
Intuitive Surgical responds to a recent study published in the Journal of Obstetrics & Gynecology, which examines clinical outcomes, safety, and cost of robotic-assisted compared with laparoscopic hysterectomy. Read More
September 5, 2013
Intuitive Surgical Statement on Journal for Healthcare Quality Article
Intuitive Surgical responds to a recent article published in the Journal for Healthcare Quality evaluating device-related robotic surgery complications reported to the FDA. Read More
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is the global leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci® Surgical System. Intuitive Surgical's mission is to extend the benefits of minimally invasive surgery to those patients who can and should benefit from it.
About the da Vinci Surgical System
The da Vinci Surgical System is a surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci Surgical System consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art technology, the da Vinci Surgical System is designed to scale, filter and seamlessly translate the surgeon's hand movements into more precise movements of the EndoWrist instruments. The net result is an intuitive interface with improved surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for skilled surgeons to perform more minimally invasive procedures involving complex dissection or reconstruction. For more information about clinical evidence related to da Vinci Surgery, please visit www.intuitivesurgical.com/company/clinical-evidence/.
PN 1004597 Rev A 09/2013
All surgery presents risk, including da Vinci® Surgery and other minimally invasive procedures. Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions. If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary. Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da Vinci Surgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.
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