Model Number C-VH-4000 |
Device Problem
Image Resolution Poor (1306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/30/2015 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 dissection tip was clouded.A replacement device was opened and it had etchings on the tip but procedure was completed with this device.The hospital did not report any pt effects.
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Manufacturer Narrative
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The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).
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Manufacturer Narrative
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The device was returned to the factory for evaluation.It showed signs of clinical usage and no evidence of blood.A visual inspection did not identify any non-conformity.A functional test was conducted on the dissection tip.The device was attached to a reference endoscope and viewed on an evh 50 mh endoscope system camera; there was clear visibility through the dissection tip, distortion was not observed.We were not able to visualize the reported issue during our evaluation.The reported complaint for "blurry/less visible" image through the dissection tip was unable to be confirmed.
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Search Alerts/Recalls
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