Intuitive Surgical, Inc. revealed that it will recall 129 lots of its Single-Site 5mm reusable curved cannulae used in combination with its da Vinci robotic surgery system after receiving reports of injuries due to cannula damage.
However, the Sunnyvale, CA-based medical instruments maker stated that the injuries were in fact caused by improper placement of the cannulae in the Single-Site port. The recalled lots were manufactured between Dec 2010 and Aug 2012 and sold to 600 customers worldwide, involving 5,200 cannulae, according to an Intuitive Surgical spokesman.
The affected devices were shipped to Australia, Belgium, Brazil, Chile, Colombia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, the U.K. and the U.S.
The recall notice did not impact the company’s share price at all due to optimism triggered by the approval of Intuitive Surgical’s new robotic system, known as da Vinci Xi. da Vinci Xi has longer instrument shafts enabling greater reach for surgery. Shares of the company rose 5.0% to close at $518.50 yesterday.
Intuitive Surgical received reports of 98 incidents of damage to the cannulae in 19,000 procedures performed using the affected devices, implying a damage occurrence rate of 0.5%. In order to avoid the injuries, Intuitive Surgical decided to restate the labeling for the Single-Site devices giving instruction for inspecting and handling the cannulae for use.
Intuitive Surgical stated that if inspection reveals damaged devices, they should be quarantined and returned to the company for replacement. The company will replace all the affected cannulae with a fresh version that can withstand higher force and is less likely to become damaged by improper placement.
Intuitive Surgical’s robotic surgical systems came under fire in the past due to several incidents that raised doubts about the robotic surgical technology. Several reports have revealed that patients suffered complications or injuries owing to the robotic-assisted surgeries. However, it seems that the company is trying its best to promote robotic-assisted surgery as an alternative to conventional surgery.
Intuitive Surgical generates revenues from da Vinci systems as well as disposable instruments that are replaced after each procedure. da Vinci system uses robots, cameras and a remote-control console to perform gall bladder removals, hysterectomies, cardiovascular operations and prostatic surgeries.
Currently, Intuitive Surgical retains a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical instruments industry include Cynosure, Inc. , Enzymotec Ltd. , and Syneron Medical Ltd. . All of them sport a Zacks Rank #1 (Strong Buy).