(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare handle felt stiff and when closed it did not cute through the tissue.The procedure was completed with another captivator ii.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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