It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophagogastroduodenoscopy (egd) procedure performed in the esophagus on (b)(6) 2019.According to the complaint, during the procedure, the product was defective.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
|