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Catalog Number 284002 |
Device Problem
Suction Failure (4039)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.(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.
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Event Description
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It was reported by the sales rep via phone that during an unspecified surgical procedure, it was observed that when the shaver is plugged into the fms vue i pump, the suction did not work.The rep stated that the rollers may be worn.There was no harm or delay in case as they were able to use another like device.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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Manufacturer Narrative
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Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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).
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Manufacturer Narrative
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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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the device was received at the service center and evaluated.Operational and diagnostic analysis does not confirm the reported issue (when plugged into shaver the suction did not work).However, the repair and testing of the unit will not be completed at this time because there is no need for it in the pool due to excess units in the pool at this time.Unit placed into long term hold.Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6) 2017 and passed all functional testing before being returned to the customer.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.Udi: (b)(4).
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Search Alerts/Recalls
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