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).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used in the colon during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, when the physician was using coagulation, there was a brief flame where the tip of the plastic and the snare come together during cauterization of a polyp in the colon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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