Intuitive Surgical has issued a nationwide recall for certain cannulae components used with the da Vinci Robot, due to the risk that the parts may be damaged during use and could be hard to replace. To date, at least one patient has experienced injuries that may have been caused by a damaged cannula, which occurred when the tube rotated and punctured the patient’s abdomen. In addition to the problems with the cannulae components, the da Vinci Surgical Robot has been linked to numerous internal organ injuries, as well as at least 70 deaths since 2009.
What’s the Problem?
The da Vinci Robot cannulae recall was announced on March 25, 2014, and according to Intuitive Surgical, the parts affected may be prone to damage after use:
“If cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instruments may come in inadvertent contact with tissue,” a warning letter issued by Intuitive stated. “This contact may cause tissue injury and require additional surgical and/or medical intervention.”
This recall includes 129 lots of Intuitive’s Single-Site 5mm Curved Cannulae for the da Vinci Surgical Robot. Components affected by the recall were made between December 2010 and August 2012, and were shipped to the U.S., Belgium, Canada, Denmark, France, Germany, Greece, Italy, Lebanon, Monaco, The Netherlands, Norway, Saudi Arabia, Switzerland, Turkey, and the U.K.
To date, Intuitive says it has received nearly 100 reports of damaged Single-Site 5mm Curved Cannulae parts, estimating that the problem may occur in approximately 1 out of every 200 components. The company is advising customers to identify affected components, inspect them for damage, and quarantine those parts if they appear to have suffered damage.
Da Vinci Robot Complications
The da Vinci Surgical System was approved by the FDA in July 2000 for laparoscopic procedures, making it the first robotic system to be used in U.S. operating rooms. The device allows the surgeon to get closer to the surgical site than would typically be possible, and work at a smaller scale than conventional methods permit. The robot consists of a control/viewing console and three to four surgical arms (depending on the model). When it was first released, the da Vinci Robot was primarily used for gynecological procedures, but has since been increasingly used in prostate and gallbladder removal surgeries, as well as heart surgery, hysterectomies and prostatectomies.
Unfortunately, problems with the device, including possible design flaws and a failure by Intuitive to provide proper training on use of the robot, have led to numerous injuries and complications including:
- Surgical burns to arteries or organs
- Peritonitis (painful and tender inflammation of the lining of the abdomen)
- Excessive bleeding
- Burning of nearby organs including the intestines
- Punctured blood vessels, organs or arteries
- Burns and/or tears of the intestines
- Severe bowel injuries
- Punctured or cut ureters
- Vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy)
- Additional surgical procedures following robot surgery
- Wrongful death
Experts estimate that surgeons may require up to 200 procedures before they know how to use the da Vinci Robot correctly, which means that during this lengthy learning period, a large number of patients will suffer outcomes that are inferior to what would have otherwise occurred with an experienced surgeon. Da Vinci Robot Lawsuits contend that surgeons were not properly trained on use of the device, which may increase the risk of complications and injuries to patients.