September 5, 2013 — In a study published in the Journal for Healthcare Quality, researchers from Johns Hopkins University are warning about under-reporting of adverse events associated with the Da Vinci Surgical Robot.
Researchers are concerned that under-reporting may under-estimate the actual risk associated with robot surgery. Although studies have found that complication rates are similar for robot surgery and traditional surgery, the actual complication rate for robot surgery may be higher.
Although 1 million of the surgeries have been performed since 2000, the FDA has received only 245 reports of complications, including 71 deaths — suspiciously low numbers for a complex medical technology. The researchers also found several cases that were only reported to the FDA after they made national headlines, up to four years after the incident occurred.
According to the lead researcher, Dr. Martin Makary:
“Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”
One problem is that there is a lack of standardization and clarity in adverse event reporting. The FDA tracks incidents caused by problems with devices, but they do not track incidents involving user error. The researchers argued that user errors should be tracked because they are more common in robot surgery.
The researchers concluded that gynecological procedures, had the highest rate of complications, accounting for 22 of 71 deaths. Hysterectomies (surgical removal of the uterus) accounted for 43% of injuries, usually due to excessive bleeding.
Intuitive Surgical, the manufacturer of the Da Vinci Surgical Robot, received a warning letter in July 2013, following a facilities inspection that found “objectionable observations” regarding the company’s handling of complaints and a recall.