The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 mdr will be filed.
|
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the seal biopsy cap continuously came off the scope.Additionally, it caused the patient's bodily fluid to spray.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
|