Model Number CYF-VHR |
Device Problems
No Display/Image (1183); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device was received and evaluated.Evaluation determined that the device was found with leaks and black image.Bending section was found detached and insertion tube was observed with dents.In addition, ¿a-rubber glue¿ was found with a crack.The device was placed for repair.Based on evaluation findings, the reported failure was confirmed.Failure likely attributed to users handling and or maintenance issue.
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Event Description
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It was reported that the device exhibited loss of id scope no image, it would not connect correctly.The issue occurred during preparation for use.There was no patient involvement on this report.No user injury reported.
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Manufacturer Narrative
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This supplemental report is to advise that upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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