Model Number URF-V |
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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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 17, 2021, it was found that the angulation of the subject device was locked since the wire for angulation operation was broken.Other detailed information was not provided.There was no report of patient injury associated with the event.
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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.Based upon the information from the olympus local service department, olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred since the angle mechanism of the subject device was corroded due to the leak of the instrument channel.The exact cause of the leak of the instrument channel could not be conclusively determined.
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Search Alerts/Recalls
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