Catalog Number 2101-0200 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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When cup inserter has been washed it seems like something is coming out from the thread.It is not known if it is metal debris or blood.
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Event Description
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When cup inserter has been washe it seems like something is coming out from the thread.It is not known if it is metal debris or blood.
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Manufacturer Narrative
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Reported event: an event regarding cleaning issue involving a cutting edge impactor was reported.Conclusion: it was reported that when the cup inserter were washed, something was coming out from the threads.The device was discovered during inspection.Additional investigation is required into this issue to determine where the debris is coming from.Further investigation of the returned device noted that no debris were observed on this part.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
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Search Alerts/Recalls
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