Navigation Links
Da Vinci Surgical Robot Update: FDA Issues Class 2 Recall of Intuitive Surgical’s da Vinci Robot due to Possibly Inadequate Testing of 30 Units, Notes Parker Waichman LLP
Date:7/15/2013

New York, NY (PRWEB) July 15, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to the U.S. Food and Drug Administration (FDA), Intuitive Surgical sent Urgent Device Correction notices to all affected customers on June 27 regarding the fact that 30 da Vinci surgical robots may not have been properly tested. Calling it a class 2 recall, the FDA issued a July 11 statement on its website noting that the affected parts are the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.

The FDA added that factory testing on those four components "may not be in compliance with UL Standards” because one of the testing devices was malfunctioning.

“As the FDA noted, it is critical for medical device manufacturers to ensure they are compliant with all applicable regulations,” said William J. Dubanevich, attorney at Parker Waichman LLP. “What is of concern here is whether or not the potential failure to properly inspect the 30 subject surgical robots could have exposed surgical patients to an increased risk of surgical complication.”

Aggressive marketing by Intuitive and whether the company is providing adequate training are among other issues related to the da Vinci, the only surgical robot approved in the U.S. for soft-tissue surgery.

On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers not to let aggressive marketing overshadow the risks of robot-assisted surgery. According to the news release, there is no good evidence to show that procedures with the da Vinci surgical robot are even as good as less invasive, far cheaper alternatives. ACOG, a group that represents 56,000 physicians, is not the only organization to express concerns about the safety and efficacy of robot-assisted surgery.

Also in March, the Massachusetts Board of Registration in Medicine has also highlighted the potential for serious complications in an advisory. The advisory stated that, in light of growing reports of injuries associated with the da Vinci, there should be more oversight for surgeons, and patients should be better informed about the risks. The Board cited examples of patients who had suffered bleeding, adhesions and damage to the bowel and ureter; in one case, a piece of rectal tissue was mistakenly left inside a patient’s abdomen.

Parker Waichman LLP continues to offer free legal consultations to alleged victims of da Vinci surgical robot injuries. If you or a loved one experienced surgical burns, perforated or torn organs, torn blood vessels or other injuries that could be associated with the da Vinci surgical robot, please contact their office by visiting the firm's da Vinci Surgical Robot Lawsuit page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

Read the full story at http://www.prweb.com/releases/da_vinci_FDA_recall/07/prweb10929191.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. EVINCI results could lead to 75 percent reduction of invasive procedures for patients with suspected CAD
2. Da Vinci Surgery Robot Lawsuit Website Launched by Bernstein Leibhard LLP to Inform Public about Potential Da Vinci Surgery Complications
3. Da Vinci Robotic Procedure Offers a Surgical Solution for Endometriosis; Now Available at Women’s Excellence in Endometriosis in Oakland County, Michigan
4. Da Vinci Robotic Surgery Lawsuit News: Ohio Law Firm Investigates Da Vinci Robotic Surgery Complications as Settlement is Reached in Louisiana Da Vinci Robot Lawsuit
5. As Da Vinci Surgery Robot Lawsuits Mount, Marketing Claims Questioned in Wake of New Study, Alonso Krangle LLP Comments
6. Da Vinci Robotic Surgery Lawyers at Wright & Schulte LLC Disturbed by Allegations of Aggressive Marketing Tactics in Pending Da Vinci Robotic Surgery Lawsuit
7. New York Medical Malpractice Lawyer David Perecman Urges Surgical Patients to Question Use of da Vinci System Surgical Robot
8. Da Vinci Robotic Surgery Lawsuit: Parker Waichman LLP Responds to Doctor’s Testimony Alleging Intuitive Surgical’s Robotic Device Contributed to a Man’s Death
9. As Da Vinci Robot Lawsuits Mount, Bernstein Liebhard LLP Applauds Surgeon’s Call for More Stringent Robotic Surgery Training
10. Da Vinci Surgical Robot Lawsuit News: Rottenstein Law Group Comments on Testimony in Ongoing Robot Trial
11. Da Vinci Robotic Infographic Released by d’Oliveira & Associates Expresses Concerns over Surgical Device
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... California (PRWEB) , ... June 27, 2016 , ... "FCPX ... fully customizable inside of Final Cut Pro X," said Christina Austin - CEO of ... unique style. Final Cut Pro X users can now reveal the media ...
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency ... named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... to their offering. The ... commercial environment for MedImmune to enter. The US ageing population ... to drive considerable growth for effective anti-influenza medications. The introduction ... considerably, but development is still in its infancy. ...
Breaking Medicine Technology: