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).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.
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It was reported to boston scientific corporation that a seal biopsy valve was used in esophagogastroduodenoscopy (egd) procedure performed on an unknown date.According to the complainant, during device exchange, the biopsy cap detached from the scope and the physician was sprayed with fluid, on his neck.The physician wiped off the fluid from his neck and completed the procedure with another seal biopsy cap.There was no serious injury nor adverse patient effects reported as a result of this event.
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