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Model Number FGS-0313 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 capsule which detached early, about eight hours into a 48-hour procedure.The data retrieved was not sufficient, hence the patient will have to repeat the study.There was no patient injury.
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Search Alerts/Recalls
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