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)(6).(b)(4).Investigation results: a seal biopsy cap was received for analysis, a visual evaluation of the returned device showed no signs of damage.The device appeared normal, and the cap closed normally.No other issues were noted.Based on the evaluation of the returned device, it is possible that an instrument larger than the recommended diameter was used in conjunction with the biopsy seal valve.It is likely that operational factors, such as device handling caused or contributed to the complaint.Therefore, the most probable cause of the reported event is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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It was reported to boston scientific corporation that a seal biopsy valve was used on an unknown date.According to the complainant, during preparation, the top part of the biopsy valve opened and sprayed.The procedure was completed using the original seal biopsy valve.No patient complications have been reported as a result of this event.
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