FDA-Device2013-08-28Class II
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Endogastric Solutions Inc
Hazard
Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.
Sold states
Distributed nationwide and Italy.
Affected count
5192 units in the US and 41 units outside the US
Manufactured in
8210 154th Ave NE, N/A, Redmond, WA, United States
Products
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1982-2013Don't want to check this manually?
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