The exact date of the event is unknown.The provided event date of (b)(6) 2021 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 small oval stiff snare was to be used during a colonoscopy procedure performed on an unknown date.It was reported that during the procedure, the device would take much longer burn to cut through the target polyp.They felt that the burn was not clean as the other sized snares that they use and are wondering if it was an issue with the cautery unit (endostat) or possibly their settings on the cautery unit.The patient had perforation and it was unknown how it was resolved.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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