Model Number GF-UE160-AL5 |
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 has not been returned to omsc but was returned to olympus europa (b)(4).(b)(4) checked the subject device and found that the reported phenomenon could not be duplicated.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 from the facility that during most likely a therapeutic procedure, it was found that the balloon channel was clogged.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 the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the information from oekg, there was the possibility that this phenomenon was attributed to the aging degradation and so on considering passed years from the manufactured year.Also this phenomenon might be attributed to the user¿s handling because the subject device had been used long time significantly beyond durable life of the subject device.
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Search Alerts/Recalls
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