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Catalog Number C-VH-1111 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was cloudy during testing.
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Manufacturer Narrative
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(b)(4).This is a reusable oem device; therefore, a lot history review is not applicable.Based on the serial number provided, we were unable to find when the device was sold to the account.The certificate of conformance (c of c) was not available for review because, the reported serial number does not appear to be included in any of the batches received in maquet (b)(4).
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was cloudy during testing.
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Search Alerts/Recalls
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