Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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 captiflex small oval flexible snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, they were having trouble with cold cutting.It appeared like they were pulling through the tissue rather than a clean cut.They were also having difficulty with cautery.Reportedly, there were no signs of blanching (tissue turning white).The snare securely attached to the active cord and there were no visible issues noted with the cautery pin.They tried to troubleshoot the device by reopening and closing it.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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