Endogastric Solutions Inc – FDA Warning Letter, Sep 30, 2009

During an FDA inspection from September 11-30, 2009, of Endogastric Solutions Inc. in Redmond, Washington, the firm's EsophyX2 device was found to be misbranded and adulterated.

The device was misbranded under 21 U.S.C. 352(t)(2) due to failures in Medical Device Reporting (MDR). Specifically, the firm failed to submit reports to the FDA after receiving information suggesting the EsophyX2 device may have caused or contributed to a serious injury, as required by 21 CFR 803.50(a)(2). Examples include Complaint 2009-0196, where a malfunctioning device caused a helical retractor to catch the esophagus, and a July 29, 2009 complaint involving esophageal injury during device removal. The firm also failed to develop, maintain, and implement written MDR procedures and event files, as required by 21 CFR 803.17 and 803.18, with inadequate documentation for complaints 2009-0156, 2009-0182, and 2009-0196.

The device was also adulterated under 21 U.S.C. 351(f)(1)(B) because the firm lacked an approved premarket