There have been an increasing number of complaints of complications, including burns, punctured vessels or organs, excessive bleeding and deaths, which are believed to be associated with the use of the da Vinci surgical robot during surgery. In response to the rise in complaints and concern over the safety of its use, the FDA has launched an investigation to determine whether Intuitive Surgical, Inc.’s device is responsible for the allegations in the complaints.
Manufacturer Warns of da Vinci Burn Risk
In May 2013, Intuitive warned hospitals that a component used in its da Vinci surgical robot system may be putting patients at risk for burn injuries. According to the company’s urgent notification, some versions of the system’s Hot Shears may be prone to small cracks, potentially creating a pathway for an electro-surgical charge. Unfortunately, the cracks may not be visible. The company has already received one report of injury linked to a cracked instrument. Despite the risk, the company has elected not to recall the Hot Shears and announced that it would begin to remove the affected instruments from hospitals when a replacement becomes available. It is estimated that this will begin between two to four weeks from the date of the company’s notification.
Uses of the da Vinci Surgical Robot
The da Vinci surgical robot, manufactured by Intuitive Surgery, is an alternative surgical method to laparoscopic procedures and has increasingly gained popularity with hospitals since its FDA approval in 2000.
The robot is designed to perform minimally invasive surgery in procedures including urologic, laparoscopic, gynecological and non-cardio theracoscopic surgical procedures.
Some examples in which the robot has been chosen over its alternative procedure, laparoscopic surgery, include:
- Complete or partial hysterectomies
- Treatment of uterine fibroids
- Kidney disorders
- Prostate removal procedures
- Throat and kidney cancers
- Endometriosis
- Heavy intrauterine bleeding
- Surgeries to reduce obesity
It is often chosen by hospitals and doctors over laparoscopic surgery due to Intuitive’s claims that the procedure is as safe as laparoscopic surgery, yet reduces recovery time in patients.
There have been no conclusive studies showing the da Vinci robot is a better or safer choice for doctors performing minimally invasive procedures—in fact, there are many signs that indicate its negative attributes outweigh its benefits.
Costs of the robot significantly outweigh those of laparoscopic surgeries, surgery takes longer, and recovery times have not been proven to be substantially shorter than other similar procedures. Additionally, there have been no conclusive studies that the robot is a safer or better choice than other minimally invasive procedures. A study being released soon blames a lack of testing prior to distribution for many of the complications which have arisen.