Model Number 7500617 |
Device Problems
Circuit Failure (1089); Solder Joint Fracture (2324); Noise, Audible (3273)
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Patient Problem
No Information (3190)
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Event Date 10/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No report of injury to patient or user.Initial findings following olympus (b)(4) investigation is that burnt smell was caused by dust.The endosonic was not regularly maintained as advised by the instructions for use.Olympus keymed have requested the product is returned for further investigation.Reported in an abundance of caution.
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Event Description
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A burnt smell occurred from endosonic.
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Manufacturer Narrative
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Olympus keymed investigation completed.Failure was a known fault defective solder joints on transducer tabs.A design change was implemented and a service bulletin created to cover this mode of failure.There has been no report of injury to patient or user.This event was reported in an abundance of caution.This will be the final follow up report.However, if any new information is received the case will be re-opened and investigated further.
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Search Alerts/Recalls
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