A growing number of dangerous malfunctions by the da Vinci surgical robot has put the device in the spotlight once again, and is increasing concern among regulators about its safety.
According to breaking news reports by CNBC and various other media outlets today, the robot, made by Intuitive Surgical, has seriously malfunctioned in a variety of ways during surgeries and is racking up a string of incident reports in the U.S. Food and Drug Administration’s “adverse event” database.
The types of malfunctions reported by the media and on the FDA database include:
- Instrument cable breaks that render the da Vinci robot non-functional and requires an instrument change
- During one hysterectomy, according to the FDA database, the robot’s arm jumped, causing the instrument … to stab an artery, which led to bleeding that the surgeon was able to control and successfully complete the procedure.
- In another hysterectomy, reported in the FDA’s adverse event database, the patient’s ureter was damaged. During repair of the patient’s ureter, the urologist noted that the jaw on the EndoWrist instrument installed on the patient side manipulator arm was not articulating correctly. … Unable to resolve the issue, the surgeons had to repair patient’s ureter and complete the surgical procedure using open surgical techniques.
- In yet another hysterectomy, the bipolar instrument fired unintentionally during a procedure. The instrument tip touched the patient’s uterus but the procedure was successfully completed.
- In still another hysterectomy reported to the FDA, it was reported … the da Vinci system hit the patient in the face. It is not known, according to the report filed, if the patient was injured during this incident. The surgeon, however, made the decision to convert the procedure to traditional open surgical techniques.
In addition to the above reports being filed with the FDA, more malfunctions and problems with the robot are coming to light as part of depositions now being given by surgeons who have used the robot.
Today’s media reports about the robot, which is made by California-based Intuitive Surgical, are just the latest incidents to make headlines. The robot has been tied to at least 70 deaths since 2009.
The FDA is reportedly working to determine whether the problems with the robot result from design problems or user error, including inadequate surgeon training. The agency is reportedly considering recalling the system if the injuries and deaths continue to increase.
The robotic system, which costs approximately $1.8 million, was designed to facilitate complex surgeries and is operated by a surgeon using a console. The FDA cleared the system for use in 2000.