The US Food and Drug Administration has received numerous reports of injuries and fatalities related to surgery performed with the Da Vinci robotic surgery system. Though injuries range from punctured organs to developing pneumonia following surgery, one of the most common types of injuries is organ burns. Patients are being burned and electrocuted during surgical procedures, which is damaging blood vessels and organs and triggering uncontrolled bleeding. Many of these patients have needed emergency follow-up surgery and experience pain and complications, even after corrective procedures.
Robot Scissors Cause Burn Injuries
The manufacturer of the Da Vinci robot, the Intuitive Surgical, Inc., published a warning in May 2013 warning surgeons and patients of the risk associated with the electrical scissors (called EndoWrist Hot Shears Monopolar Curved Scissors) used during Da Vinci surgery. The electrical scissors are used to cut and cauterize tissue during procedures. The risk occurs when micro-cracks develop in the protective insulation and from electricity arcing and burning tissue outside the surgical area.
By July 2013 in response to issues with organ burns, the FDA issued a warning letter to Intuitive Surgical, Inc., informing them of problems noticed during inspections in the spring of that year. The company had already begun warning customers (hospitals and surgery centers) of the scissors issue because of complaints received from users. Other design defects were also noted in the reports, including cleaning procedures that led to sparking and tears in the protective covers of the scissors.
The monopolar scissors are used to perform electrosurgery. Like the other tools on the Da Vinci robot, the scissors are controlled by a surgeon via a console. An electrical current runs though the scissors and is used to cut, coagulate, and cauterize tissue during surgery. The problem occurs when an electrified part of the instrument touches one that is metal, but not electrified. The insulation is intended to create a barrier between the surfaces, but it has failed to do so during many procedures.
There have also been issues with user error. If an unpracticed surgeon fails to operate the Da Vinci robot properly, in can result in an unintentional firing of the electrical equipment. Basically, the electrical current is activated when it should not be. The combination of user error, insulation failure, and general mechanical malfunction has resulted in a number of serious injuries.
Robotic Surgery Burns Recorded in the FDA Database
The FDA’s database listed the following instances of injury related to Da Vinci robotic surgery burns:
- Prostatectomy procedure in which scissors flamed, sparked, and smoked at the joint when activated by the surgeon. The sparking and flames were accompanied by reports of a garlic odor.
- Hysterectomy procedure in which patient’s injuries proved fatal. Burning occurred to the right external iliac artery, which resulted in blood pumping into the body cavity. This caused bowel ischemia.
- Sparking of the scissors arced and sparks reached patient’s artery. There was visible charring.
- Prostatectomy procedure in which arcing caused the burning of tissue.
- Hysterectomy procedure in which blood vessels were burned and injuries proved fatal. Follow up procedures included blood transfusions and an emergency laparotomy.
How We Can Help
If your doctor has suggestion Da Vinci robotic surgery, you need to be aware of the risks associated with the procedure. The surgery is more expensive than other comparable options and offers few additional benefits.
In addition to burning, patients must be aware procedures performed by robot include risk of:
- Extended surgery time
- Blood vessel damage
- Severe bleeding
- Extended recovery time
- Organ and tissue damage
Make sure you understand how these risks affect you and ask your surgeon if Da Vinci surgery is truly the best option for you. If you or a loved one has been injured during robotic surgery or you are experiencing side effects that could be related to surgery, you must take action. We can help you explore your options and determine the best path of action to deal with your specific case.