Note: this report pertains to one of five alliance syringe used during the same procedure.Manufacturer report# 3005099803-2017-02937 pertains to the first device, manufacturer report# 3005099803-2017-02940 pertains to the second device, manufacturer report# 3005099803-2017-02941 pertains to the third device, manufacturer report# 3005099803-2017-02942 pertains to the fourth device and manufacturer report# 3005099803-2017-02943 pertains to the fifth device.It was reported to boston scientific corporation that five alliance inflation syringes were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a balloon was inflated using the alliance inflation syringe.However, the gauge did not accurately register the pressure as the balloon was being inflated.It was noted that an attempt to inflate to 20 atm was made but the gauge needle would not go past 18-19 atm.The following four syringes had the same issue, and the procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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