Note: this manufacturer report pertains to one of two symphion resecting devices that were used on the same procedure.It was reported to boston scientific corporation on (b)(4) 2019 that two symphion resecting device was used for a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an error was received stating low pressure detected, resection on hold and it was noted that there was saline leaking from the patient.The device was changed to another symphion resecting device since it was thought that there was a device malfunction due to the error.The second device was used and there was more saline noted that was flowing out from the patient.The physician was able to successfully resect, however it was noted that there less return flow of saline and there was a total deficit of 2,200 ml.A laparoscopy procedure was needed and it revealed a lot of saline was in the belly of the patient.The physician suspected possible perforation but successfully completed the procedure after the saline in the belly was removed.
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