Date of event: 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, (b)(6) 2020.(b)(4).The device has not been received for analysis; 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 symphion controller unit was used in a procedure performed on an unknown date.According to the complainant, during the procedure, a resecting device failed.The procedure was cancelled due to this event.There were no patient complication reported as a result of this event.
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