Catalog Number C-VH-1111 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/30/2017 |
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 after sterilization and cleaning preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry and needed repairing.Hospital discontinued use of scope and used an alternative scope to complete procedure.Scope was not sent out for repair.No patient involved.
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Manufacturer Narrative
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Internal complaint number: tw# (b)(4).Autonumber: (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/serial conforms to all applicable product specifications.The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.No visual defects observed.An image quality inspection was performed with an endoscopic video imaging system.Specks and blurry spots were observed on the images.Based on the results of the evaluation, the reported failure mode "poor quality image" was confirmed.
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Event Description
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The hospital reported that after sterilization and cleaning preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry and needed repairing.Hospital discontinued use of scope and used an alternative scope to complete procedure.Scope was not sent out for repair.No patient involved.
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Search Alerts/Recalls
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