The exact date of the event is unknown.The provided event date of july 01, 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the physicians had issues with the sensation snare.The snare would not cut completely through the small polyp.Reportedly, the snare was securely attached to the active cord and signs of tissue blanching (tissue turned white) were noted.He said multiple technicians were having a hard time opening the snares after withdrawing the snare back into the catheter to reposition.The technician said she felt resistance and all of a sudden the snare shot forward to fully open.The procedure was completed and the polyp was removed with a biopsy forceps.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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