Study: Problems with Surgical Robots Going Unreported to the FDA
November 5, 2013 2:36 PM
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Some of these problems have resulted in the injury or death of patients
A new study shows that some problems and even deaths caused by
were not accurately reported (or in some cases, not reported at all) to the U.S. Food and Drug Administration (FDA).
According to PBS, the study looked at the da Vinci Robotic Surgical System specifically, which is made by
. It's designed to perform complex surgeries with a minimally invasive approach while being controlled by a surgeon from a console. Medical professionals say the system provides smaller incisions, shorter hospital stays and less pain post-operation.
The study searched through several data bases over about a 12-year period of use of the da Vinci Robotic Surgical System. The study found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries.
However, they also found eight cases where reports were inaccurate, including five cases where no FDA report was filed at all.
This is a pretty big deal, considering hospitals are required to report the incident to the manufacturer if a device malfunctions in any way, and then the manufacturer reports it to the agency. From there, the FDA creates a report for its Manufacturer and User Facility Device Experience database.
Da Vinci Robotic Surgical System
"The Journal for Healthcare Quality article gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the FDA," said Intuitive Surgical in a statement last month. "Intuitive Surgical can only report adverse events after it becomes aware of them. We take this requirement very seriously and make every effort to account for all reportable events--even those from several years prior."
One such case was a patient's injury and death in 2009, but the incident couldn't be found in the FDA's database for that year. The study's authors found a "very late" report matching the patient's case in 2010. The FDA received the report two weeks after
The Wall Street Journal
ran a story about it.
This has raised questions for the need of a better standardized system for reporting malfunctions and other problems regarding
the surgical robots
It also raises another important question: if problems occur during robotic surgery, is the doctor, the hospital or the manufacturer responsible? According to PBS, this introduces the potential issue of product liability.
Intuitive Surgical also called for the study's authors to conduct a study that compares the under reporting of traditional open and laparoscopic surgical issues with robotic-assisted surgery.
The use of robots for laparoscopic surgery, which uses smaller incisions than in traditional surgery, was approved by the FDA in 2000. From 2007 to 2011, the number of da Vinci systems installed was boosted by 75 percent in the U.S. (compared to about 800 to 1,400 prior).
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Need to compare with human error numbers too
11/5/2013 3:34:10 PM
245 sounds like a lot of errors, and clearly it's not acceptable. But if there are 2000 or of these things in use on a regular basis that's not a large percentage of overall operations. I wonder how it compares to the stats for human error in similar operations.
It seems like this is something that needs to be investigated further.
RE: Need to compare with human error numbers too
11/5/2013 5:33:01 PM
It's the FDA. Anyone who deals with them on a regular basis can assure you--they're investigating.
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