It was reported by the sales rep from switzerland that preoperatively to an anterior cruciate ligament (acl) repair procedure, it was observed that the pump on the inflow tubing fms vue 24pk device did not stop filling the water.It was reported that after a complete check it seemed the only issue was with the tubing.After changing the tubings everything was fine.It was not reported if there were any delays in the surgical procedure.There was no patient involvement reported.There were no reports of 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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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.H10 additional narrative: e3: reporter is a j&j sales representative.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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