Model Number URF-V2 |
Device Problem
Break (1069)
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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 december 1, 2021, it was found that the bending rubber and bending section were damaged.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 manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.Omsc presumed that it was damaged by an irregular load such as a strong twisting operation to the left and right with the bending section fixed at an angle or a sudden angle operation.
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Search Alerts/Recalls
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