Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is not available for return; 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 sensation short throw was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the physician felt the sensation short throw was clinically inferior to captiflex and could not perform the needed cut effectively.The procedure was completed with a non bsc device.There were no patient complications reported as a result of this event.
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