Below are Intuitive Surgical statements released to the public.
May 2, 2014
Intuitive Surgical Remedies Violations Found by FDA
In an 8-K posted on May 1, 2014, Intuitive Surgical, Inc. announced that the Food and Drug Administration has completed an evaluation of the Company's corrective actions. These corrective actions were made in response to a FDA warning letter dated July 16, 2013. The FDA indicated in a letter to the Company dated April 25, 2014, that based on the FDA's evaluation, it appears that the Intuitive Surgical has addressed the violations contained in the July 16, 2013 warning letter. The April 25, 2014 FDA letter is attached below.
May 2, 2014
First Quarter 2014 FDA Audit
The Form FDA-483 observations (FEI Number 3001675293) have been edited to redact (obscure) Intuitive Surgical's confidential and proprietary information. This redacted version of the 483 form has also has been provided to the FDA for their official files.
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.
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. For more information about clinical evidence related to da Vinci Surgery, please visit www.intuitivesurgical.com/company/clinical-evidence/.
Note: Press releases and published articles are provided for informational purposes only. Material contained in these publications does not imply that specific clinical uses are safe and effective nor do they imply regulatory clearance unless specifically stated. Please see our FDA Clearance page for a description of clinical uses for which the da Vinci® Surgical System has been cleared for use in the United States.
Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.
Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.
Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci® Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to http://www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.
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