Catalog Number 6541-4-808 |
Device Problem
Flaked (1246)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/09/2014 |
Event Type
malfunction
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Event Description
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I was covering a case for raphiel jones and spd personal showed me a part with green coating coming off after wash cycle of reprocessing.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been (b)(4) other events reported for the reported manufacturing lot visual inspection: the handle is worn an degraded.The damaged device was discovered during inspection; 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.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
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Event Description
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I was covering a case for (b)(6) showed me a part with green coating coming off after wash cycle of reprocessing.
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Search Alerts/Recalls
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