If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The defect reported could not be verified.Performed service and repair functions.Reviewed service history.Attach box label, software upgrade form, and fms vue final testing.The unit was evaluated and the reason for return : " no suction " could not be duplicated.Performed software upgrade to the latest versions.Replaced springs on pressure arm housing (preventive maintenance) with tip replacement kit.The unit passed all diagnostic tests, functional tests, and is fully operational.Details can be found in the attached reports.A review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.A review into the depuy synthes mitek complaints system revealed one similar complaint for this device's serial number.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported by the sales rep that during a knee scope surgery, it was observed that the fms vue had no suction.It was reported that the pump was switched to solo mode and worked properly to complete the procedure.There was no delay in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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