Model Number UM-S20-17S |
Device Problems
Defective Device (2588); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was received and evaluated.Device evaluation confirmed the customer reported issue.Inspection found probe was damaged with crush and bubbles inside probe tip which resulted in unit failed to display good ultrasound image.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, bent tip, there maybe fluid in the sheating.The issue found during an unspecified procedure.There was no patient harm or injury reported due to the event.No user injury reported.
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Manufacturer Narrative
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Section e3 (occupation) has been updated to reflect the correct information obtained.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the damaged probe could not be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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