Catalog Number 0250070620 |
Device Problems
Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that white residue was found on the probe of the product.The white residue was noticed at the beginning of the case when they were opening the packaging.
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Manufacturer Narrative
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The particle/debris condition was not confirmed since the unit was not received.As per risk document likely root causes are: manufacturing/assembly error, incorrect or inadequate packaging, severe shipping conditions.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that white residue was found on the probe of the product.The white residue was noticed at the beginning of the case when they were opening the packaging.
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Search Alerts/Recalls
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