Catalog Number C13888-01-00 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A customer reported that the irrigation / aspiration tip was sharp.The timing of the event and patient impact are unknown.This is the second of two reports for this facility.Additional information has been requested but none has been received.
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Manufacturer Narrative
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No polymeria tip sample has been returned for evaluation for the complaint of having sharp edges.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because a sample was not returned and no lot information is available, the root cause for the customer complaint issue cannot be determined.(b)(4).
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Manufacturer Narrative
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Additional information provided in device available for evaluation?., device evaluated by mfr?, evaluation codes., and additional mfr narrative.Two opened irrigation / aspiration (i/a) tips were received in wrenches for the report of very sharp edge.A visual inspection was performed and the returned samples were found to be conforming.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.The returned samples were found to be conforming, therefore the sharp edge as described in the complaint cannot be confirmed from this evaluation.A root cause cannot be determined for the complaint as described by the customer.(b)(4).
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Search Alerts/Recalls
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