Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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 in a colonoscopy/esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cap came off and the physician was sprayed with fluid.It is noted that there is not enough hold to seal the cap on.The procedure was completed with another of the same device.There was no serious injury nor adverse patient effects reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
|