FDA to Investigate Growing Number of Adverse Events using da Vinci Surgical RobotMar 1, 2013
Federal health officials have launched a formal investigation into the safety of surgeries performed by the da Vinci surgical system robot after hearing many complaints from recipients of procedures done by this device.
According to a report from Bloomberg News, the Food and Drug Administration has asked leading hospitals with the da Vinci surgical robot to submit reports of complications they have encountered using the trendy device. Even though the da Vinci robot has only been approved for limited surgical uses, the amount and range of procedures being performed using the robot has increased exponentially in the last few years and more hospitals are choosing to purchase the machine, believing they’re gaining a market advantage by doing so.
The da Vinci surgical robot is manufactured and marketed by Intuitive Surgical Systems and each unit costs in excess of $1.5 million. The company has already drawn the ire of federal regulators who believe the hospitals that purchase these may be doing so out of unwarranted pressure from the company that tells officials at these facilities that buying the expensive equipment will keep them competitive with other hospitals.
Now, health officials want to hear about the growing number of reports of injuries sustained by patients who undergo a procedure that uses the da Vinci robot instead of a traditional open or laparoscopic surgery.
The da Vinci robot is touted as being able to provide less invasive surgery and faster recovery times. An increasing number of surgeries are being performed using the robot, including gallbladder, hysterectomy, and other procedures. And as use increases so do the number of injuries and complications experienced during and after those surgeries.
The FDA has already received adverse event reports from victims of a bad surgery using the da Vinci robot. Many of these reports, according to Bloomberg, involve the robot’s use during gynecological surgeries. Injuries reported include damage to ureters and the bowels. Patients who’ve undergone a surgery using da Vinci have also experienced burns and instances in which instruments used by the robot have broken off inside patients.
While many of these reports were actually submitted by Intuitive Surgical, the company is hesitant to blame its own machine. Instead, the company blames the operator of the device performing the surgery for the errors.
Regulators have decided to launch the investigation to determine whether the increasing number of reports of problems encountered using the da Vinci robot reflects problems with the device or some other issues.