da Vinci Surgical Robot Recall: Warning of Problems with Monopolar Curved Scissors
UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
The contents of this page are provided for informational purposes only
Late last week, Intuitive Surgical sent a letter to hospitals and doctors warning about a risk of problems from the da Vinci surgical robot, where invisible cracks may develop in certain instruments. This may cause patients to suffer severe electrical burns to the bladder, bowel or other internal organs during robotic surgery, posing a serious and potentially life-threatening risk.
Although the manufacturer is not directing hospitals to stop performing da Vinci robotic surgery or removing the defective instruments from the market, the FDA should classify this action as a da Vinci robot recall, as it appears that use of components may pose a risk of serious adverse health consequences or death.
Update June 11: According to a report by MassDevice.com, Intuitive Surgical has begun shipping replacement parts for the da Vinci robot, which the manufacturer claims are not prone to develop micro-cracks.
Recall Comes Amid Reports of da Vinci Robotic Surgery Burns
Saiontz & Kirk, P.A. represents individuals throughout the United States who are pursuing a da Vinci robotic surgery lawsuit after experiencing burns, tears or other severe internal injuries that may have been caused design defects or inadequate training provided by Intuitive Surgical about the proper use of the surgical robot.
While our da Vinci surgery recall lawyers have been reviewing potential claims involving design defects with the device for more than a year, the mainstream media has just recently started to focus on the mounting number of injuries suffered following robotic surgery, highlighting cases where individuals suffered burns, tears and severe internal bleeding that may have been caused by the da Vinci robot.
In an “Urgent Medical Device Notification” dated May 8, Intuitive Surgical now acknowledges that there may be a risk of “micro-cracks” developing in certain versions of its Hot Shears Monopolar Curved Scissors.
These micro-cracks in the da Vinci robot scissors are often not visible to the surgeon or hospital staff, yet it may create a pathway for electrosurgical energy to leak to the tissue during robotic surgery, causing a thermal injury or electrical burns.
Decision Not To Label it a Recall for da Vinci Robot
While injuries caused by the micro-cracks in certain Monopolar Curved Scissors appears to pose a substantial risk of severe internal injury or wrongful death following da Vinci surgery, Intuitive Surgical has not labeled the action as a voluntary “recall”, allowing the defective da Vinci robot scissors to remain on the market.
According to a statement provided to CNBC, Intuitive Surgical defended the decision not to issue a da Vinci robot recall, indicating:
“[Intuitive Surgical] considered the risk to patients of removing the product from the field, which included cancelled or postponed surgeries in cancer patients as well as conversion to more invasive open surgical procedures. The company determined that the risks of device removal before a replacement could be offered outweighed the risks of leaving the existing product in the field.”
There are many problems with this line of reasoning, not the least of which is that there are already substantial questions over whether da Vinci Surgery provides any long term benefits, so converting surgeries to tradition procedures does not pose any increased risk to patients.
Multiple studies and medical groups have already expressed concerns in recent months that the short-term benefits provided by robotic surgery may not justify the increased costs and risk of complications, and that was before the manufacturer disclosed that some of the da Vinci instruments may suffer micro-cracks that could cause electrical burns or injuries.
There is also a lack fo data supporting that da Vinci surgery provides any long-term benefits over other procedures, so it is highly suspect that Intuitive Surgical would keep these instruments on the market and allow patients to be exposed to the risk of complications.
The likely answer to why they are not describing this as a da Vinci surgical robot recall is that hospitals have paid millions of dollars to purchase the complex machine and millions more have been invested in promoting robotic surgery as a superior alternative to traditional procedures.
da Vinci Surgery Warnings and Precautions Outlined in Letter
The letter provided to customers does not indicate when replacement Hot Shears Monopolar Cautery Scissors without the potential for micro-cracks will be available. It appears that Intuitive Surgical may not have been willing to voluntarily take on the loss of procedures and increased media attention for that period of time.
Unfortunately, as a result of Intuitive Surgical’s decision to place their desire for profits before consumers safety, patients may suffer:
- Surgical Burns to the Bladder, Bowel, Arteries or Other Organs
- Tears or Perforations to Bladder, Bowel, Arteries or Other Organs
- Complications Resulting in Additional Surgical Procedures Following Robotic Surgery
- Wrongful Death following da Vinci Surgery
While it is allowing the da Vinci robot to remain on the market, Intuitive Surgical has offered several warnings and precautions regarding use of the EndoWrist Monopolar Curved Scissors, suggesting that these instructions will help avoid problems where the electrical current will arc outside the surgical field and injure nearby arteries, organs and tissue.
The letter cautions surgeons not to “air fire” the cauterizing effect, advising only to activate the electrical current when the scissor tips are in direct contact with tissue. They also warn surgeons to be aware of patient anatomy that may come into contact with the Hot Shears, to survey the surgical field around the da Vinci scissors, not to exceed the maximum recommended settings, only to use validated instruments approved for use with the robot and to consider whether the patient may be more susceptible to burns.
Our lawyers will be closely monitoring this latest development and how the FDA responds to this action. In many cases the FDA will classify such “Urgent Medical Device Notifications” as a recall even when the manufacturer attempts to avoid using that language.
Based on the available classifications used by the FDA, the da Vinci robotic surgery recall should be categorized as a Class I Medical Device Recall, because use of the Hot Shears Monopolar Curved Scissors poses a substantial risk of severe injury or death.
Investigations into da Vinci Surgical Robot Problems
Earlier this year, the FDA launched an investigation into the mounting reports of problems and complications following da Vinci robotic surgery. The agency sent a survey to doctors in January asking them to outline instances of issues with the da Vinci Robot, as well as for information on the training received for da Vinci robotic surgery and insights into what procedures the surgical robot is best and worst for performing.
The FDA has received thousands of reports involving da Vinci surgery deaths and injuries in recent years. According to an analysis of adverse event reports submitted to the FDA, Intuitive Surgical has consistently denied that these problems were caused by da Vinci robot, even in cases where burns were suffered to internal arteries and tissue, which do not burn themselves.
UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
The contents of this page are provided for informational purposes only
10 Comments • Add Your Comments
Laura says:
I went in for a da vinci hysterectomy on April 23, 2013 and my Dr said he punctured my bladder and it was to bad to do my hysterectomy and he h a d to repair my bladder. I was on a catheter for two weeks while my bladder healed. I was scheduled to go back in tomorrow, June 6, but it was cancelled due to the recall
Posted on June 5, 2013 at 9:25 pm
Marie says:
I had the davinci hysterectomy done in Dec 2010 and came through with no complications. I felt great and still do. It’s better than being cut open and having the recovery time take longer whereas after my surgery I was back to driving in a week. My doctor and the military general surgeon were fantastic!
Posted on June 11, 2013 at 3:31 pm
Julie says:
I had my davinci hysterectomy on April 2, 2013. I am still in mild to severe pain. My surgeon will not see me and keeps referring me to my PCP. She has suggested I get a second opinion. I was even in his office seeing a NP and bleeding new blood and in severe pain after ultrasound a few days before. He still would not see me and suggested I may have a twisted colon? I have no colon issues and no idea where this came from. I am scared and confused and hope my new Dr. has an answer for me on Friday. I can not rock my baby or even stand for more than a few minutes without awful burning and inflammation pain? I am taking pain meds and they are the only thing that helps. Trying to space them out to make them last longer. It is a bad way to live when you have to decide when to suffer and when to use a pill…..I wish I never had this done.
Posted on June 19, 2013 at 8:49 am
Linda says:
I have been also having problems since my surgery.
Posted on July 2, 2013 at 3:16 pm
Sharon says:
I had robotic surgery to remove an ovary and have spent the last 2 two and one half years in bed. I had many injuries- my vaginal cuff was cut or burned, an intestine cut and a bowel. I have my surgical notes and I am appalled. This was a good surgeon who knows what her training was. Sometimes they are a weekend retreat. The Da Vinci robot seems now to be like something from outer space. I want people to know. I did not ask questions or even consider the robot a hazard then. I now cannot drive for the pain even sitting. I could go on, But, please beware of the Da Vinci robot.
Posted on July 28, 2013 at 1:55 pm
Tonia J. says:
january of this year I had to have a hysterectomy to remove tumors from my uterus and cancer from my cervix. I was given a choice of robot surgery with a recovery tme of one week and traditional surgery with six week recovery time. I am a single mother of two teenage boys, i work 30 hrs. a week and make ten dollars per hour. after medical ins. is deducted from my pay i take home around $1000.00 a month, this is our only income..one week off work was the only choice. I didnt go to medical school, so i have to have faith that my doctor knows what he is doing, and i have to trust him, what else can i do? …….the surery went fine, 3 days in hospital and i went home feeling pretty good, planning to get back to work the following week. a few days passed with no problem, then one morning i woke up, got out of bed, and as soon as i stood urine gushed out everywhere, it was just like my water breaking when in labor with my boys! this continued throughout the day. i finally called my surgon, i was told he couldnt fit me in and i saw another doctor. long story short..after 2 weeks of wetting in my pants, really…wetting in my pants, non stop with no warning, tests and hours of back and forth to hospital and doctors and specialists and ultra sounds and some extremely painfull tests trying to figure out what the problem was, it was determined that my left ureter was disconected between my kidney and bladder. i had the divinci robot surgery. three minor surgerys, two tubes being put through my back conected to my kidney to catch my urine and store it in a bag that i attached to my leg and carried around with me..i finally almost 3 months later had to have major kidney surgery to re attach the ureter to my kidney. i was in the hospital for 9 days in horrible pain, my children basically taking care of themselves, i had been out of work the majority of time since initial surgery in january….all of by bills fell behind, fiends and family were feeding us, when i finally got to leave the hospital it was a good month before i was up and able to care for even myself. and i was left with an awfull deep purple half inch wide 9 inch long (from belly button to pubic area) scar. i am not a vain or modest woman but i can tell you that i will never again wear a bathing suit!! along with all of this, depresion set in being out of work, out of commission and out of my life for so long, wondering if i was ever going to be normal and pee in a toilet again, or if i would walk around carirying a bag of urine on my leg for the rest of my life……the last surgery was in april, i feel pretty good now, ( peeing in a toilet:)) still a little pain now and the,, still trying to catch up financially and emotionally. i recently recived a letter from the hospital i used for everythin, the told me they felt they could have provided me with better care, and wanted me to accept there sincere appology. and included a check for out of pocket expences
incoured from all in the amount of $86.00!!!………..my hospital and doctor bills were over $80,000,00. ins. co-pays over $500.00, medications over $400.00…………….and i can not put a price on what my children had to deal with….thats my story, and its not over yet:(
Posted on July 31, 2013 at 7:13 pm
Tonia J. says:
you are welcome…word needs to get out!!!!
Posted on July 31, 2013 at 7:15 pm
Jackson says:
I do feel for people who legitimately have an injury or long term debilitating result from any surgery. What I have a difficult time with are people who try to work the system, jumping on the band wagon and trying to make money off of the system. I read a few of the above comments and question the validity of what is being said. Are each of these cases reviewed to confirm the truths of the accusations that are being made? I would hope so. I would also hope that if the above people are lying that they too are judged and punished for false accusation.
Posted on August 1, 2013 at 8:54 pm
Tina says:
I had a full hysterectomy on Feb. 8th. When March came around I was in sever pain. I remember my doctor coming into my room and telling me he had to tact my bladder and that’s why I had a catheter in. I went back to him in March in pain. He refered me to a neouroligst. I am not the same person I was before the surgery. My legs do not function right. I can’t do ANYTHING. They are very week and I have to have help to get up and down. Muscle cramps, sharp pain, burning and sting, and some swelling. My quality of life bites. I’ve been to several doctors in my area and nobody will tell me what’s wrong. They want say it’s from surgery but I know it is. If I could be my old self the way I was before surgery I would be beyond happy!! I know that will never happen. I have a lawyer that’s telling me they need a diagnosis, cause and a treatment. I can’t find a doctor to tell me this. I live in Louisiana but willing to go to texas to see a doctor. Anybody have any Ideas? Thanks
Posted on September 12, 2013 at 11:59 pm
Betinna says:
Im a patient of this procedure I can hardly get out of bed its been 2 years ive been every where tryna figure out why im feeling like this I went back to the doctor that did it and he told me hes done with me I didn’t get the proper after care and its hard for me to accept this. nobdy else will treat me ive been in the E R over twenty times im looking for some one to help me
Posted on June 30, 2015 at 3:10 pm