Model Number UM-S20-17S |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has no image because the cable u has a cut, possibly it has moisture inside.The device was evaluated at olympus repair center.According to the evaluation, the following was found.-olympus repair center could reproduce the reported phenomenon.-insertion tube had dents and scratches.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.
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Event Description
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During reprocessing, the user found that the ultrasound probe was broken and there was blood inside the channel.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The device was evaluated at olympus repair center.According to the evaluation, the following was found.There was blood in the sheath.There was leakage from the ultrasonic medium due to breakage of the sheath.The insertion tube was bent and scratched.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc surmised that some external force was applied and a hole was generated in the distal end sheath, leading to leakage of the ultrasonic medium and blood invading through the hole.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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