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 captiflex small oval flexible snare was to be used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure and inside the patient, when trying to cut it would not cut through the target polyp.They tried to open/close and still would not cut since the device was experiencing mechanical issues.Reportedly, there was no visible issue noted with the handle and with the device.They could only complete when using cautery or biopsy forceps.The procedure was completed with another captiflex 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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