Catalog Number C-VH-1111 |
Device Problems
Fogging (1253); 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 03/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that bom 7mm extended length endoscope is not working properly anymore and is fogging up constantly.
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Manufacturer Narrative
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(b)(4).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.The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.No visual defects were observed.An image quality inspection was performed with an endoscopic video imaging system.A foggy image was obtained.The lens was cleaned and the image quality inspection was repeated.The image remained foggy which suggests the issue with the lens.Based on the results of the evaluation, the reported complaint was confirmed for the reported failure "poor quality image".
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Event Description
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The hospital reported that bom 7mm extended length endoscope is not working properly anymore and is fogging up constantly.
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Search Alerts/Recalls
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