Intuitive Surgical has issued a recall for about 30 da Vinci surgery robots that may not have been properly tested before being distributed.
The da Vinci robot recall was posted by the FDA last week, impacting systems where it was discovered that the factory testing may not have been in compliance with UL standards, after one of the testing devices was found to be malfunctioning.
An “Urgent Device Correction Notice” was sent by Intuitive Surgical to affected customers on June 27, notifying hospitals and providers who purchased one of the affected robotic surgical systems about the problem.
The FDA has categorized the action as a “class 2 recall”, which suggests that use of the product only involves a remote possibility of serious adverse health consequences and that any problems would likely be temporary or medically reversible.
According to a statement provided by Intuitive Surgical in a report by Bloomberg News, the device maker indicates that all 30 of the da Vinci robots have been subsequently tested “in the field” and all passed the tests. No complications or problems have been reported in connection with surgery using the devices that were not properly tested.
Intuitive Surgical sells about 150 of the da Vinci Surgical Systems a quarter, at a cost of $2 million a piece. During the second quarter of 2013, reported sales of the machine came in well under prior estimates amid growing concerns within the medical community about complications with da Vinci robotic surgery and a number of product liability lawsuits filed by individuals who suffered severe internal injuries.
This latest recall for the da Vinci robotic surgery system comes after a prior warning issued in May 2013, where the manufacturer indicated that certain components used with the da Vinci machine, known as Hot Shears, may be prone to develop microcracks that could allow the electrosurgical energy to “leak” to nearby tissue and cause thermal injury to internal organs. Replacement parts for the da Vinci robot began shipping last month, which are reportedly not prone to suffer these micro-cracks.
In January, the FDA began reviewing the safety of the da Vinci robot, sending a survey out to doctors asking them to detail any da Vinci robot issues that they have encountered, including information on patients who suffered internal injuries or death, as well as details about their training in the use of the device.
The Massachusetts state medical board has also cautioned doctors this year to review potential robotic surgery problems, risks and benefits carefully when selective patients for the procedures.
The Massachusetts advisory came shortly after the American Congress of Obstetricians and Gynecologists (ACOG) issued a report recommending against robotic hysterectomy surgery, indicating that there is a lack of evidence showing any benefit to patients compared to other means of doing a hysterectomy, yet there are increased costs and a serious risk of complications.
Intuitive Surgical also faces a growing number of da Vinci robot lawsuits brought by former patients who suffered burns, tears and other complications that were allegedly caused by a defective design for the robot and failure to provide adequate warnings about the risks. Many of the complaints also claim that the manufacturer failed to adequately train surgeons on proper use of the device.