The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 mdr will be filed.
|
It was reported to boston scientific corporation that a seal biopsy valve was used in colonoscopy procedure performed on an unknown date.According to the complainant, during procedure, the seal biopsy valve flipped opened and the physician and the patient were sprayed with water and stool.Additionally, it was reported that there was no intervention done because they were wearing ppe.The procedure was successfully completed with this device.There was no serious injury nor adverse patient effects reported as a result of this event.
|