Approximated based on the date the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 an unknown date.According to the complainant, during the procedure, the coagulation connection came off.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 fine.
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