Model Number URF-V2 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on december 2, 2021, it was found that the angulation of the subject device was locked due to corrosion of the angle mechanism due to the air leak of the subject device.Other detailed information was not provided.There was no report of patient injury associated with the event.This device is an olympus asset.
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Manufacturer Narrative
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The subject device was returned to olympus service operation repair center (sorc).A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.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.Olympus medical systems corp.(omsc) was informed from olympus service operation repair center (sorc) that it was found that the instrument channel of the subject device was leaking.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred since water entered the subject device from the leak point and the angle mechanism was corroded.
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Search Alerts/Recalls
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