Orbera Intragastric Balloon System Apollo Endosurgery

The risk of balloon deflation and intestinal obstruction and therefore possible death related to intestinal.

Orbera intragastric balloon system apollo endosurgery.

The device listed in this medical device report is an orbera intragastric balloon catalog number b 50000. The patient continued to get sicker with nausea fatigue dizziness. Please confirm or provide the model lot serial and or catalog number s of the device listed in the medical device report as applicable. Apollo endosurgery grf 00345 00r07 6.

The patient was discharged and prescribed xarel. For more information regarding apollo endosurgery go to. Important orbera intragastric balloon system safety information. Table of contents 2.

Apollo endosurgery grf 00346 00r07 page 1 of 31 orbera intragastric balloon system orbera directions for use dfu rx only apollo endosurgery inc. The orbera intragastric balloon system is manufactured by apollo endosurgery and the reshape integrated dual balloon system previously manufactured by reshape medical inc was acquired by apollo. Orbera intragastric balloon system. Apollo s products are offered in over 75 countries today and include the overstitch endoscopic suturing system the overstitch sx endoscopic suturing system and the orbera intragastric balloon.

Important orbera intragastric balloon system safety information. What to expect procedures for orbera. A patient with the orbera intragastric balloon had a pulmonary embolism thirteen days post placement and spent four days in the icu. The current international orbera intragastric balloon system directions for use dfu addresses the known and anticipated potential events of death nausea vomiting and cardiac complications as follows.

The orbera intragastric balloon system is a weight loss aid for adults suffering from obesity who have tried other weight loss programs such as following supervised diet exercise and behavior modification programs but who were unable to lose weight and keep it off. About the orbera. Before using product read the following information thoroughly. Apollo endosurgery grf 00345 00r07 1.

Apollo s products are offered in over 75 countries today and include the overstitch endoscopic suturing system the overstitch sx endoscopic suturing system and the orbera intragastric balloon. The orbera balloon is a single use device therefore the device is no longer in use.