Model Number TJF-260V |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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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 the olympus local service department on november 9, 2021, it was found that inside of the light guide lens was dirty.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 the olympus local service department.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.Olympus medical systems corp.(omsc) was informed from the olympus local service department that it was found that the subject device was leakage.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 this event could not be conclusively determined.Olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred due to the following cause.- the moisture entered the subject device from leaking point and components inside the light guide lens got corroded and the corrosion product may have remained under the light guide lens as dirt.
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Search Alerts/Recalls
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