Robert Lowes
April 30, 2013
A spike in the number of adverse event reports (AERs) associated with the da Vinci Surgical System (Intuitive Surgical) last year has prompted the US Food and Drug Administration (FDA) to survey surgeons about their experience with this technology for robot-assisted surgery.
Some of the AERs on file with the FDA pertain to equipment malfunctions that resulted in no harm to patients during operations that ranged from hysterectomies to coronary artery bypass graft surgery. Other reports describe injuries and deaths, although they are not necessarily blamed on an equipment problem. In some cases, surgeons who operated robotic arms and the various tools attached to them punctured bladders, severed nerves and blood vessels, and otherwise appeared responsible for the mishaps.
In other cases, the da Vinci surgical robot seemed to have a life of its own, at times inexplicably cauterizing a fallopian tube, damaging heart tissue, or refusing to let go of a patient’s tissue with its grasper. “We had to do a total system shutdown to get the grasper to open its jaws,” stated one report, noting that the patient was not injured.
The number of AERs for the da Vinci Surgical System filed with the FDA’s Manufacturer and User Facility Experience (MAUDE) database increased 34%, going from 211 in 2011 to 282 in 2012. During that period, the number of procedures performed with the da Vinci system in the United States increased 26%, going from 292,000 to 367,000, according to a quarterly report that Intuitive Surgical filed earlier this month with the US Securities and Exchange Commission (SEC).
Through the first 3 months of 2013, MAUDE received 62 reports, putting the robot-assisted surgery technology on track to amass 248 AERs this year. Many AERs are filed by the manufacturer itself. Other reports come from hospitals, clinicians, and patients.
Table. Spike in AERs on the da Vinci Surgical System
| Year | No. of da Vinci Procedures in the United States | Change | No. of AERs Filed With FDA | Change |
| 2012 | 367,000 | 26% | 282 | 34% |
| 2011 | 292,000 | 28% | 211 | −2% |
Source: Intuitive Surgical SEC filing; FDA MAUDE database
In January 2013, the FDA asked surgeons whose hospitals belong to the agency’s Medical Product Safety Network to participate in a 10-question telephone survey about the da Vinci Surgical System. Surgeons were asked, among other things, about user training, common equipment repairs, patient selection, the complications they saw and how they compared with those seen in conventional surgeries, and what procedures are the best and least suited for the da Vinci technology.
FDA spokesperson Synim Rivers told Medscape Medical News that the FDA conducted the survey “after we observed an increase in the number of reports we received about the da Vinci Surgical System.” An upward trend in AERs, Rivers said, does not necessarily mean that a medical device is faulty. Sometimes, upswings occur because more clinicians are using the device.