Model Number CLV-180 |
Device Problem
Component Missing (2306)
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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 events.The exact cause has been under investigation.Therefore, 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 of the subject device for repair at olympus (b)(4), it was found that the magnet and its holder on xenon lamp housing were missing.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems india (omsi).The manufacturer record was unable to be checked as the subject device was manufactured more than 15 years ago.The exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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