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Study Says Complications Related to Robot Surgery Underreported

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Over the past couple of years, the da Vinci surgical system has been linked with serious injuries, including tears and burns to internal organs, vaginal cuff dehiscence, and cut ureters. Some patients have filed lawsuits in an attempt to recover damages from manufacturer Intuitive Surgical.

Now, Johns Hopkins University researchers published a study in the Journal for Healthcare Quality showing more injuries and deaths linked to Da Vinci robotic surgery than have previously been reported. Though FDA figures list 245 cases of patient injury since 2000, the researchers stated that figure is “very, very low,” suggesting the problems are under-reported.

Study Shows Several Cases Not Reported

Researchers undertook this study to evaluate device-related robotic surgery complications reported to the FDA. They searched the FDA’s database, LexisNexis (an online database of lawsuits for legal research), and the Public Access to Court Electronic Records (PACER) system. In all three databases, they identified those complications that occurred over a 12-year period between January 1, 2000 and August 1, 2012.

They then cross-referenced what they found in the FDA database to the results from the other two, to determine cases where an FDA report was inaccurate, filed late, or not filed at all.

Results showed the following:

  • A total of 245 events were reported to the FDA, including 71 deaths and 174 nonfatal injuries
  • 8 cases were identified from the LexisNexis and PACER searches where FDA reports were improperly filed. In five of these, no report was filed at all. The other three were filed late—beyond the 30-day regulation time.

Researchers concluded that if this many severe cases were not reported to the FDA, there are probably many more that were not reported. Lead author Marty Makary, M.D., laparoscopic pancreas surgeon, told HealthLeadersMedia that one attorney in Louisiana had identified about 20 patients harmed by robotic surgery who filed malpractice claims. If the 245 figure reported by the FDA was accurate, that attorney would have 10 percent of all the complications that had occurred from the robot over the last decade.

“That’s a data point that makes you think this number is just far too low,” he said.

FDA Asking Questions

The FDA approved the da Vinci Robot in 2000 for use in urologic, laparoscopic, gynecologic, and non-cardiovascular thoracoscopic surgical procedures. It has four arms and is operated by a surgeon who sits at a console with a video screen. The device was advertised as providing a less invasive option for many surgeries, including prostate removal and gall bladder removal, leaving smaller scars and reducing blood loss.

Patients who have filed lawsuits against Intuitive Surgical claim the device was defectively manufactured, and may cause injuries because of a malfunction, or because of insufficient surgeon training. A March 2012 study published in the Journal of Clinical Oncology found that women treated for endometrial cancer experienced no additional benefits when the da Vinci was used than if they received traditional surgery.

Earlier this year, after the FDA noticed a 34 percent increase in reports of adverse events associated with the robot, they started surveying physicians using the system to gain answers about its strengths and weaknesses. The agency also faulted the company in May 2013 for failing to report measures it took to guard patients from accidental electrical burns.