The U.S. Food and Drug Administration (FDA) has announced Class II recalls of two different components of the da Vinci surgical system, which uses robots to perform procedures. The agency also released new training and credentialing recommendations for hospitals and doctors using the devices. The recalls – which involve instrument arms that can become stuck and part of the robot hand that can detach – are the latest in a series of regulatory and legal woes for Intuitive Surgical Inc. (ISI), the da Vinci maker.
With more than 70 products liability cases filed against the manufacturer in federal courts and dozens of others filed in state courts, ISI is now defending itself against its insurance carrier, Illinois Union Insurance Co. That company is trying to rescind products liability coverage and contends that ISI concealed its potential risk for additional lawsuits. The increasing numbers of lawsuits and recalls highlight the da Vinci robots’ safety issues.
In December, the FDA announced a Class II recall of 1,386 da Vinci systems following ISI’s urgent device notification regarding complications with the instrument arms, which may suddenly stall and become stuck due to abnormal friction. Class II recalls are issued when a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” In one reported incident, this friction led to the robot making an imprecise cut during the transection of a urethra, and in two other cases, the doctors had to stop using the robot mid-procedure and switch to alternative surgical methods.
The FDA also issued a Class II recall following ISI’s urgent device recall for certain lots (manufactured between 2007 and 2011) of da Vinci EndoWrist needle drivers – which hold and guide the surgical instruments – because the drivers’ jaw inserts can detach. ISI has reported 82 incidents related to damaged or detached needle driver jaw inserts, including 27 incidents where the inserts fell off during surgery. In one case, a device fragment was not retrieved during surgery after falling into the patient, so a second operation was required to remove it.
These recalls, combined with an increase in the number of adverse event reports submitted to the FDA in 2013 – 3,697 reports involving death, injury, or malfunction as of early November, compared with 1,595 in 2012 – prompted the agency to call for hospitals and doctors to engage in additional training before using the robots. The FDA recommends that all surgeons be appropriately credentialed. There are different da Vinci models and users must be made aware of that doctors should also be trained on each one of these models.
There is some debate over the source of the reporting spike, but medical researchers say that underreporting adverse events is a problem. In September, Johns Hopkins researchers published a study in the Journal for Healthcare Quality that said robot surgery complications were underreported and that a standardized robotic device reporting system should be created. The number of reported adverse events is on the rise in part because the robots are being used for a variety of different surgeries, including hysterectomies, prostatectomies, gastric bypasses, and cardiac procedures.
Earlier this year, the FDA announced it was surveying doctors about the challenges they face when using the da Vinci systems. The FDA released its final report in November. But it should be noted that only 11 surgeons were surveyed. Ten of the 11 respondents reported problems with the robot arms. It was reported that there were approximately 400,000 surgeries using the robot in 2012.
Illinois Union filed a lawsuit in October demanding rescission of the products liability coverage policy it issued to ISI in March. It alleges in the suit that ISI concealed the existence of tolling agreements that froze the statute of limitations until after the policy was issued. The insurer claims that ISI has no idea how many products liability lawsuits may be filed. Illinois Union said it would not have issued the policy if it had had an accurate risk assessment.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.