The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a spyscope ds ii was used in the bile duct during a procedure performed on an unknown date.Reportedly, there were no issues noted with the spyscope ds ii during the procedure.According to the complainant, during the procedure, a bile fistula was observed.Reportedly, the bile fistula was confirmed when the spyscope ds ii was used to clean the bile duct with water supply and suction.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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