This supplemental report is to correct the initial mdr.The initial medwatch reported the during the therapeutic esophagogastroduodenoscopy (egd) with dilation of gastric sleeve, there was difficulty with forceps insertion and passing the dilatation balloon through the working channel on the evis exera iii gastrointestinal videoscope causing a prolongation in the procedure.Two disposable dilation balloons were wasted and after two balloons would not pass (but cleaning brush would pass), a different gif-h190 and a new balloon were used without issue.The procedure was not cancelled or postponed, and was completed with another similar device.The procedural delay is not considered life-threatening, nor did it lead to a permanent impairment in the patient.The initial report was reported out of caution as the iuc is unknown-pae.However, all the final fuc codes are non-pae.Additionally, the prolongation of the procedure has been determined to be not a serious injury.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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