FDA Kept a Hidden Database of Surgical Stapler Malfunctions
The Food and Drug Administration recently acknowledged that it maintained a hidden database of surgical stapler malfunctions. The “alternative summary” system contained over 56,000 reports of problems with the devices between 2011 and 2018. These non-public reports made up over half of the total reports the agency received regarding malfunctioning staplers.
The disclosure came before an advisory meeting that was held to determine if surgical staplers should be upgraded to a higher-risk classification. The staplers are currently in a low-risk category with other medical devices, including tongue depressors and bandages. Given that the FDA received tens of thousands of malfunction reports, Jack Mitchell, Director of Health Policy at the National Center for Health Research, wondered why the agency did not reclassify surgical staplers sooner.
Surgical staplers are typically used in minimally invasive surgeries to cut and seal tissue and vessels. When they malfunction, they can cause substantial harm to patients, often leading to excessive bleeding or infections. Since 2011, over 400 surgical stapler-related deaths were reported to the FDA’s public system, MAUDE.
In 2018, Ohio-resident Mark Levering suffered a serious brain injury as a result of a stapler malfunction. Attorney Chad Tuschman, who is representing Levering in a lawsuit against the surgeon, hospital, and manufacturer Covidien, has stated that he is appalled by the FDA’s hidden report disclosure. “It shocks the conscience,” he told Kaiser Health News. He also questioned the reason malfunctions were allowed to be reported to an alternative database that was not made accessible to the public.
Michigan-based surgeon, Doug Kwazneski, told Kaiser Health News that it is important to have access to information about malfunctioning medical devices in order to prevent continuing issues.
In February of 2019, surgical staplers became ineligible for reporting to the FDA’s hidden database.
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