Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a procedure performed on (b)(6) 2021.During the preliminary check, the physician powered on the controller, checked the correct power switch and connected the spyscope ds ii into the controller, but it did not work.They used two demo scope with this controller; however, an image was still not visible.The procedure was not completed due to this event.It was reported that the procedure was performed the next day, after the spyglass ds was exchanged.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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