The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 medium hexagonal stiff snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the snare would not cut cold or with heat and the tissue was damaged.The procedure was cancelled due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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