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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Manufacturer Narrative
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The subject device was not returned to omsc for evaluation but was returned to (b)(4).(b)(4) checked the subject device and found the reported 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 the service department of olympus (b)(4), it was found that the inside of light guide lens was dirty.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the reported information and past similar case, omsc surmised that dirt entered from the gap at adhesive around the light guide lens which generated by physical stress and so on.The instruction manual of the subject device states appropriate handling.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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