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As if robotic surgery doesn't already conjure images of creepy robot fingers in your opened guts, new research out of Johns Hopkins suggests that we don’t know the full scope of complications from robot-assisted surgeries because they are not adequately reported to the FDA.
The report, published in the Journal of Healthcare Quality, focuses on the Da Vinci system, a popular robotic setup used for laparoscopic procedures and sold by Intuitive Surgical, a firm that's having a less than stellar year. The researchers looked at three different databases for evidence of complications with Da Vinci: LexisNexis, the legal records of PACER, and the FDA’s own MAUDE.
They found 245 reports brought to the attention of the FDA, a number that seems pretty low given that the timespan for their search spanned twelve years, during which over a million surgeries were performed. On double-checking with PACER and LexisNexis, the team also discovered an additional eight instances of injury that were not reported, reported late, or reported inaccurately to the FDA. This suggested to them that a hard and fast procedure is not yet in place for declaring and collecting accounts of surgical robotic error.
Another bothersome fact: two of the eight questionable reports were only filed once media outlets, namely The Wall Street Journal and Reuters, picked up on the cases.
With comparatively new technology, transparency is key. Robotic surgery already has a pre-existing problem here: as the Johns Hopkins team noted, the marketing surrounding Da Vinci is often directed straight towards consumers and does not mention the risks associated with the product.
But despite their report of laxity in reporting complications, the researchers say that the potential benefits of robotic surgery are numerous. Their intention is not to take down a burgeoning field of medical innovation, but rather critique its lack of standardization before it becomes a larger problem.
“Overall, robotic surgery has shown great promise to improve many procedures,” the report states. “As robotic surgery grows, it is important that the true incidence of complications that occur with the system be known to ensure continued safe innovation.”