There could soon be new rules for a common medical device that's caused hundreds of deaths.

The Food and Drug Administration (FDA) held hearings Thursday to raise the requirements for surgical staplers.

For decades, manufacturers have been allowed to file summary reports, hiding problems with medical devices. The KVUE Defenders did a report on this practice earlier this month.


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The FDA took a closer look at those reports and discovered between 2011 and 2018, there were nearly 110,000 reports of surgical staplers malfunctioning. More than 11,000 people suffered serious injuries and 412 people died.

There is currently very little testing required for surgical staplers, but the hearings held Thursday are expected to change that.

If you have had experiences with medical device dangers, we encourage you to join the Medical Device Dangers Facebook group.