This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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It was reported by the sales rep that prior to an unknown surgical procedure performed on (b)(6)2024 it was observed that the when the tubing of the fms vue ii pump-shaver box device was on and ready to go, would click run and leave run on clamped off.When the device was unclamped, it was not keeping pressure in the chamber and was continuously flushing.The pump device was swapped out and the procedure was completed.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.
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