DaVinci Surgical System Poses Unusual Patient Risks for Gynecological Surgeries
The daVinci surgical system has been in the forefront of the national news lately. Manufactured by Intuitive Surgical, the daVinci is a complex robotic system which is represented as being a way in which various surgeries can be performed in a minimally invasive manner. The company represents that because the surgeries are “minimally invasive”, there is less scarring, less blood loss, and less surgical recovery time for the patient.
To use the system, the surgeon controls the giant robot from a console. Through small incisions, the tips of the robotic arms are maneuvered from the console to perform surgery. The device is most often used in hysterectomies and other gynecological procedures, but it can be used for other surgeries, including prostate surgery.
Use of the system is NOT without risk, however. The FDA’s MAUDE system lists approximately 20,000 adverse events involving the daVinci over the last decade. The list contains catastrophic injuries and 274 deaths. In fact, there have been reported injuries to the ureter, colon, and other tissue and body organs. There have been reported injuries to arterial vessels, causing extensive blood loss.
According to a recent report by NBC News, the daVinci has also had 175 recalls. While some of the recalls were initiated for minor revisions and changes, some were also required to prevent additional patient injury. Perhaps most unexpected, there have been thermal, or burn injuries reported by doctors and patients. In a 2013 Warning Letter issued to the manufacturer, the FDA noted problems caused by electrical arcing. Specifically, it has been reported that electricity arced from the tip of the robotic arm to the patient’s flesh, causing the patient to suffer burn/ thermal injuries. Certainly, most patients who agree to undergo “minimally invasive” surgery do not expect electrical burn injuries to tissue or body organs.
While some of the problems with the daVinci are related to the dangers of the device itself, other problems are attributable to lack of surgeon training on the device. It is reported that a surgeon’s inadequate training is a leading cause for patient injuries. It might surprise patients to know that there are no training requirements imposed on a surgeon before a surgeon
can use the device. While the manufacturer offers training, it does not require training before the device is sold. Further, the FDA has stated that it has no authority to oversee a surgeon’s training or to impose training requirements on a surgeon before the device is used on patients.
Thus, a patient given the option of surgery with the daVinci system is faced with a daunting choice: either opt for an open procedure with all of the usual risks and down-time of the procedure, or agree to the robotic technique and trust that the patient’s surgeon has the capability to control the robot without incurring injury.