As if the Intuitive Surgical wasn’t facing enough problems with its da Vinci Surgical Robot, the U.S. Food and Drug Administration (FDA) announced that the mechanical arms on some of the da Vinci robots could stall during robotic surgery, which could result in health problems or serious injury. This recall affects approximately 1,386 Patient Side Manipulators, also referred to as the “instrument arm,” used on the da Vinci S, Si and Si-e Surgical Systems.
According to the Class II recall notification, the FDA believes there is a remote possibility of serious complications, but the defect may cause “temporary or medically reversible” complications.
Intuitive Surgical has warned medical facilities and medical providers that the da Vinci robotic arms need to be replaced. According to at least three complaints, friction within the PSM instrument arms may interrupt the da Vinci robot arm movement, causing them to stall or get stuck. The company said surgeons who use the system may experience a feeling of resistance but if they continue to push that resistance, the device could stall and then “suddenly catch-up” to the correct position.
Although Intuitive Surgical claims that none of the incidents have led to da Vinci surgical complications, the FDA has received one report of an imprecise cut and two cases of perceived resistance.
Intuitive Surgical said it has completed 70 percent of the inspections and claim that most devices had no problems. They said they would inspect affected robots and repair or replace arms if necessary.
As we have mentioned in the past, the da Vinci has been accused of inadequate training for surgeons, resulting in patients suffering from tears, burns and even death. The design of the da Vinci has been said to be defective because the MCS instruments could develop tiny cracks near the distal portion of the shaft creating electrosurgical energy to leak into tissues during use, which could potentially cause serious burns internally.
After being touted as the next best thing to replace traditional surgery and promise for the future, many experts question using the da Vinci for routine hysterectomy surgeries, saying these procedures are more costly and do not result in better results for the patient. The Robot is still not as precise as they had hoped.
This year the number of adverse incidents reported to the FDA involving the da Vinci robots has almost doubled. With so many lawsuits to come, the future of Intuitive Surgical remains questionable.
If you or a loved one has been injured following a robotic procedure, feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).