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Catalog Number 225003 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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: unavailable.
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Event Description
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It was reported by the affiliate that during an unknown procedure the vapr generator ea (115001), vapr2 footswitch *ea, vapr handpiece *ea could not be activated.No patient consequence and no surgical delayed was reported.No additional information was provided.
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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.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.Investigation summary : the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Furthermore, an invalid lot number was provided which precludes conducting a manufacturing record evaluation.As the device was not returned, we cannot determine a definitive root cause without a physical evaluation.However, the likely root cause of the reported failure would be fair wear and tear due to age and use as this product code was no longer manufactured after 2010, therefore the complaint device is at least 9 years old.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:unavailable.The udi is unknown and unavailable.
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Manufacturer Narrative
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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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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Search Alerts/Recalls
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