(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 captivator small hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, several physicians are complaining about the captivator snare in regards to cutting polyps.They reported that they have been experiencing a "dull cut." also, it was reported that the failure to cut was due to the resistance felt when actuating.Reportedly, no other issues were noted with the device.The procedure was completed with another non bsc snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
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