da Vinci Surgical Robot Class II Recall Issued, Reports D. Miller & Associates, PLLC

Houston, TX 7/24/13 – A class II recall has been issued for thirty of Intuitive Surgical’s da Vinci surgical robots. The surgical robots were recalled after one of the devices was found to be working improperly.

Thirty of Intuitive Surgical’s da Vinci surgical robots have been recalled after one of the devices was found to be working improperly.* Additionally, the FDA’s statement about the recall suggests the devices might not have been tested properly. A class II recall is issued when the probability of serious health consequences is remote, according to the FDA’s definition.**While 30 devices might not sound like a lot, these systems are only located in about 2,000 facilities, according to Intuitive Surgical, Inc’s website.

Intuitive Surgical’s da Vinci system received FDA clearance under the 510(k) approval process in 2001, being cleared as a Class II device, making it subject to additional controls.*** The da Vinci surgical system is used for a variety of procedures and is touted as a minimally invasive way of completing surgical procedures, with less recovery time needed by the patient.


Even though the da Vinci system might be less invasive, a FDA warning letter issued to the manufacturer, Intuitive Surgical, Inc, on July 17th suggests the devices also have not been tested well enough after going on the market. An inspection completed by the FDA revealed a number of deficiencies, including a neglect to report injuries from the device to the FDA, according to a Bloomberg article.**** “It is important for consumer safety that manufacturers continue reporting adverse events and problems with the device after it is placed on the market,” says Darren Miller, da Vinci attorney of D. Miller & Associates, PLLC.“

If you or a loved one has been injured by a da Vinci robotic surgery, you may be entitled to compensation,” says da Vinci attorney Miller. D. Miller & Associates is diligently pursuing suits against the manufacturer, Intuitive Surgical, Inc., and continues to offer free reviews for those who think they might have a case.

About D. Miller & Associates, PLLC:
Founded in 2002 by attorney Darren Miller, D. Miller & Associates, PLLC is a national law firm with practice areas in personal injury, asbestos and mesothelioma, defective drugs and devices, business and criminal law. Based in Houston, Texas, the attorneys at D. Miller & Associates, PLLC, have successfully earned their clients compensation through aggressive litigation against even the most powerful of defendants. For a free legal consultation, contact the firm at 1-855-PRO-LAWYERS or at marketing@dmillerlaw.com . For more information, visit our website at www.dmillerlaw.com


* http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=119694
** http://www.fda.gov/Safety/Recalls/ucm165546.htm
*** http://www.accessdata.fda.gov/cdrh_docs/pdf/K011002.pdf
**** http://www.bloomberg.com/news/2013-07-18/intuitive-surgical-declines-on-warning-letter-from-fda.html

Contact Information

Andrea Pisha

Phamaceutical Legal Asst.

D Miller & Associates, PLLC

(1) 1-855-776-5299

contact@dmillerlaw.com