The FDA regulates surgical staplers as Class I medical devices. Class I devices are supposed to have minimal potential harm. And their design should be simple. Other examples of Class 1 devices include: Elastic bandages, latex gloves, tongue depressors, and bedpans. Class I devices are exempt from many FDA regulations. This includes the mandatory reporting of malfunctions and injuries. Therefore, non-fatal surgical stapler malfunctions are not on MAUDE. This stands for Manufacturer and User Facility Device Experience. MAUDE is a public database that tracks medical device failures. Medical providers rely on MAUDE for safety data. They use it to make informed decisions about medical devices. But the only data on MAUDE for surgical staplers involve fatalities. This is a tiny fraction of the total number of incidents. Instead, non-fatal incident reports went to ASRP. This is short for Alternative Summary Reporting Program. This FDA database was not accessible to the public until June 2019. Surgical stapler companies took advantage of the Class 1 classification. They could hide evidence of the stapler-caused injuries. They could report non-fatal incidents to ASRP instead of MAUDE. It took doctors a while to catch on. Many surgeons became suspicious of the low numbers on MAUDE. The number of surgical stapling incidents submitted to ASRP was high. Finally, the FDA issued a letter to health care providers warning them of the danger. From 2011 through March 31, 2018, there had been more than 32,000 stapling malfunctions. These caused: 366 deaths, and more than 9,000 serious injuries. Many of these injuries and fatalities resulted from a defective stapler. The FDA said it would reconsider its Class I classification of surgical staplers. It also issued draft guidance for surgical stapling companies.