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The FDA publicly swung into action Friday after Kaiser Health News illuminated a secret database that kept serious safety issues out of the public eye.

How it works: The FDA maintains a public database of injuries or other problems caused by medical devices. It's a valuable tool for researchers, and also for doctors, who want to assess devices' safety before using them in patients.

  • But KHN reported last week that the FDA also has a separate reporting system, whose contents are not publicly available. Roughly 100 products are allowed to use that channel, which has collected more than 1 million reports since 2016.
  • Doctors and researchers don't know about issues raised in those reports; a former FDA commissioner told KHN he didn’t even know the system existed.

Driving the news: A mountain of reports about surgical staples and staplers have piled up in the secret system, outside of public view, leaving doctors unaware of the products' risks.

  • "I don't want to sound overdramatic here, but it seemed like a cover-up," said one doctor who queried the FDA's public database — and came up empty — after experiencing problems with a surgical stapler.

A day after that story ran, the FDA sent a letter to doctors saying it's concerned about the safety of surgical staples and staplers.

The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions.

Go deeper

Why made-for-TV moments matter during the pandemic

Photo illustration: Sarah Grillo/Axios. Photos: Erin Schaff-Pool, Biden Inaugural Committee via Getty Images

In a world where most Americans are isolated and forced to laugh, cry and mourn without friends or family by their side, viral moments can offer critical opportunities to unite the country or divide it.

Driving the news: President Biden's inauguration was produced to create several made-for-social viral moments, a tactic similar to what the Democratic National Committee and the Biden campaign pulled off during the Democratic National Convention.

Updated 6 hours ago - World

Over 3,000 detained in protests across Russia demanding Navalny's release

Russian police officers beat protestesters at a rally against of jailing of oppositon leader Alexei Navalny in Moscow on Saturday. Photo: Mikhail Svetlov/Getty Images

Police in Russia on Saturday arrested more than 3,300 people as protesters nationwide demanded that opposition leader Alexey Navalny be released from jail.

Details: Demonstrations began in the eastern regions of Russia and spread west to more than 60 cities.

Updated 8 hours ago - Politics & Policy

Arizona Republicans censure Cindy McCain and GOP governor

Combination images of Cindy McCain and Gov. Doug Ducey. Photo: FilmMagic/FilmMagic for U.S.VETS/Michael Brochstein/SOPA Images/LightRocket via Getty Images

Arizona Republican Party members voted on Saturday to censure prominent GOP figures Cindy McCain, Gov. Doug Ducey and former Sen. Jeff Flake (R-Ariz.), who've all faced clashes with former President Trump.

Why it matters: Although the resolution is symbolic, this move plus the re-election of the Trump-endorsed Kelli Ward as state GOP chair shows the strong hold the former president has on the party in Arizona, despite President Biden winning the state in the 2020 election.

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