June 26th, 2013
The FDA has recently released an Observational Report concerning the Da Vinci robotic system and its problems. The FDA formally observed the following: The user of the surgical system needs to clean certain surgical instruments during the surgery. However, this requirement was never a part of Da Vinci’s original application for the design of its surgical instruments, specifically its fenestrated bipolar forceps. As a result there have been numerous side effects of arcing of the energized surgical instruments as a result of surgeons cleaning off the instruments intrasurgically by scraping them across other surgical instruments. Because these are energized surgical instruments the scraping of these monopolar curved scissors leads to tears or holes in the protective tip covers which leads to arcing which, in turn, causes side effect injuries to patients.
In our Da Vinci lawsuits we have been alleging since the beginning that this defect is caused by the Robotic System.
A copy of the FDA DHHS observation report is below.
May 8th, 2013
On May 8, 2013, Intuitive Surgical, the manufacturer of the Da Vinci robotic device formally notified all hospitals and medical providers including doctors and surgeons via a formal written notification of certain risks and side effects from the use of the robotic surgery device.
Da Vinci admitted the following problems in its advisory notification:
a. Small cracks developing in the curved scissors and hot shears;
b. Surgery patients suffering electrical burns to the bladder, bowel and other adjacent internal organs during the robotic procedure.
Nadrich & Cohen has been representing Da Vinci side effect victims for over one year. We are currently representing side effect victims in all 50 states. Side effects include:
c. Severe internal injuries causing further surgeries
The May 8th urgent medical device notification issued by Intuitive Surgical admits problems with the instrument hot shears the Intuitive Surgical Endowrist and the monopolar curved scissors. The notification addresses issues with “certain versions of the hot shears monopolar curved scissors instruments.” “We know of minor cracks in the scissor allowing a pathway for electrosurgical energy to leak into the tissue.”
Intuitive admitted on national television that it considered recalling the Da Vinci robot but concluded that the risks to patients of removing the Da Vinci robot including canceled and postponed surgeries before any device can be replaced outweighed the risks of leaving the existing robotic surgery device in hospitals.
Given the above notification Intuitive now needs to inform hospitals and surgeons when the new revised hot shears monopolar cautery scissors will be delivered and installed in the equipment.
Our clients have suffered the following from the robotic surgery device:
a. Surgical burns;
b. Tears and/or perforations to the bladder, bowel and other contiguous organs;
c. Other complications causing revision or subsequent surgery.
If you or a loved one experienced any of the above side effects following robotic surgery please contact one of our lawyers at Nadrich & Cohen for a confidential free consultation. There is no pressure. We will advise you of your rights and provide the resources you need. We are contingency lawyers so we only charge a fee if we obtain a recovery against the manufacturer.
Please contact us by either completing the “Do I Have A Legal Claim?” on the right or call us at 1-800-718-4658 to speak to a Robotic Surgery specialist.