The echo ps positioning system which is intended to be removed, was not removed from the patient during the hernia repair procedure as prescribed in the instructions-for-use.This complaint is confirmed as a use related event.A photo of the removed echo ps positioning system was provided.Based on the photo evaluation, the echo ps positioning system appears to be complete including the two mesh connectors.The surgeon indicated nothing was left in the body.As reported the ventralight st mesh was well incorporated with no problem noted.The warning section of the instructions-for-use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." the instructions-for-use also prescribes the proper method for use.Note, the bariatric surgery was being performed in a different hospital and by a different surgeon than the hernia repair procedure.Not returned.
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