FDA Keeps Secret Database Of Medical Device-Related Injuries And Malfunctions, Report Claims


An internal Food and Drug Administration database hides reports of medical device-related injuries and malfunctions away from the public eye.

Surgeon's Stapler Failure

After a surgical stapler accidentally locks up during a routine appendectomy he was helping with, Dr. Douglas Kwazneski checked FDA's database of medical device failures and found nothing.

However, upon surveying other leading surgeons, he discovered that more than two-thirds of them have had a similar experience or knew another doctor who did.

According to Kaiser Health News, the FDA has exempted the surgical staple manufacturers from the extensive public database MAUDE. Instead, malfunctions of these staplers file malfunction reports in an alternative database hidden from public view.

A Secret FDA Database

An investigation by Kaiser Health News reveals a secret internal database of injury and malfunction reports for around 100 medical devices, including surgical staplers, balloon pumps, and breathing machines.

While deaths are required to be reported in MAUDE, the alternative summary reporting program has recorded at least 1.1 million incidents in this internal repository since 2016.

In only 2017, more than 480,000 injuries or malfunctions were reported in this database. That same year, many of the device makers lost their exemptions as FDA begins a new summary reporting program.

Data concerning surgical staplers are particularly skewed. In 2016, only 84 stapler injuries or malfunctions were recorded in the public database, but nearly 10,000 malfunction incidents were found in FDA's internal database.

Stapler maker Covidien and parent company Medtronic ended their reporting exemption in 2017. Since then, the reports of issues with Covidien staples spiked from just 1,000 malfunctions or injuries in 2015 to 11,000 in 2018.

FDA, Public On Opposing Sides

"[The exemption program] has allowed the FDA to more efficiently review adverse events ... and take action when warranted without sacrificing the quality of our review or the information we receive," Alison Hunt, an FDA spokeswoman, tells Kaiser Health News in an email.

However, many medical experts and patients are unhappy with idea of so much data being kept from the public.

"The FDA is basically giving away its authority over device manufacturers," Madris Tomes, a former FDA manager who now runs Device Events, says. "If they've given that up, they've handed over their ability to oversee the safety and effectiveness of these devices."

In a report released on Saturday, March 8, FDA announces the agency's plans to review the safety of surgical staplers. A meeting will be held within the year to discuss the potential reclassification of surgical staplers for stricter control.

The agency will also be reviewing stapler malfunction reports in the public database as well as the alternative summary reports submitted to the internal FDA database.

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