Catalog Number 0935280 |
Device Problems
Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the irrigation syringe had a hair inside of it.
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Manufacturer Narrative
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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses there of are known to the ordinary individual.
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Event Description
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It was reported that the irrigation syringe had a hair inside of it.
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Search Alerts/Recalls
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