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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Manufacturer Narrative
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Sorc checked the subject device and found the phenomenon.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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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 (b)(6) 2021, it was found that the angle was locked.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Omsc presumed that the angle was locked by an irregular load such as sudden angle operation or a strong twist operation to the left and right while the bending section was fixed at an angle.
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Search Alerts/Recalls
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