Catalog Number C-VH-1111 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).Corrected to: this is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.(b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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