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Model Number FGS-0313 |
Device Problems
Poor Quality Image (1408); High pH (2426)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product sample was not returned for evaluation, however, an arcview graph was provided by the customer for analysis.The returned sample did not meet specification as received.The reported condition was confirmed.The investigation identified the root cause of the reported event to be capsule failure.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, they had a strange study.Technical support logged into the customer's computer and saw that they have a capsule failure, which showed very high ph level and blue lines throughout the study.Technical support transferred a copy of the study for review.There was no patient injury and a repeat procedure was necessary.
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Search Alerts/Recalls
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