|
Catalog Number 284002 |
Device Problem
Suction Failure (4039)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/15/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If additional information should become available, a supplemental medwatch will be submitted accordingly.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported by the sales rep via phone that the right side outflow lower lock of the fms vue pump device was not staying in place which affected suction.It was discovered intra-operatively.No patient harm reported.The procedure was shoulder surgery.Another mitek device was utilized to complete the procedure.No further information is provided.It was not reported if a spare device was available for use to complete the 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.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Udi: (b)(4).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by dfa.Depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch.A follow-up medwatch will be filed as appropriate.Udi: (b)(4).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the complaint device was received at service center and evaluated.Per service manual operational and diagnostic analysis does not confirm the reported issue (device right side outflow lower lock not staying in place effecting suction).However, found that irrigation motor is not activating due to missing magnet on left side door, replaced left side door assembly to correct issue.Replaced worn fingers on pressure arm housing (preventive maintenance) with tip replacement kit.Per sb, performed software upgrade and cpld version upgraded.The testing of the unit was completed per the service manual.The unit passed all functional tests and is fully operational.The root cause for the reported failure could not be determined.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Udi: (b)(4).
|
|
Search Alerts/Recalls
|
|
|