The Wall Street Journal–Intuitive Surgical Inc. sent customers an emergency medical notice about a potential defect in an instrument used in its da Vinci surgical robots, adding to the controversy over the devices’ safety and cost-effectiveness.
The notice is related to a scissor instrument known as Hot Shears. According to the notification, the instrument could develop small, invisible cracks, which can potentially cause a leak of electricity that can burn patients. The notice, dated May 8, informs customers of precautions to take before using the instrument to ensure patient safety.
The notice, reported earlier by CNBC, says an additional message will be sent once a replacement instrument without the potential for cracks is available.
Intuitive Surgical received one complaint of injury by an instrument later found to have “microcracks,” the notice said, but a subsequent analysis didn’t indicate energy leakage. The U.S. Food and Drug Administration had been informed of the incident, the company said.
In a statement, Intuitive confirmed that it sent the notice and said that the “company has no confirmed evidence of patient injury attributable to this issue.” The company also defended its decision not to recall the product from the market and said a replacement product would be available in two to four weeks.
Shares of Intuitive Surgical fell 2.2% to $494.49; the stock is down 11.4% over the past 12 months.
“The company 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 statement, provided through a spokesman, said. “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.”
Some research analysts downplayed the notice, saying that they are common in the medical devices field.
The “instrument is easy to replace and the issue is relegated to certain versions of the instrument, which will minimize any incurred costs associated with repairing/replacing the instrument,” said David Roman, a Goldman Sachs analyst, in a note to investors.
Intuitive shares, down 11.4% in the last 12 months, been under pressure in recent months after a medical journal article questioned the cost-effectiveness of robotic surgery compared to noninvasive surgery done by hand. Since then, the da Vinci’s safety also has come under question in lawsuits and media reports noting a rise in adverse event reports to the FDA, which the regulator has been probing through physician surveys.