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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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair of the subject device at olympus (b)(4), it was found that the air/water nozzle was clogged with foreign material.The reprocessing method of the subject device at the user facility is unknown.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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The subject device has not been returned to omsc for evaluation but was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomenon, and also surmised that this phenomenon was attributed to insufficient cleaning by the user.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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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).Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc could not conclusively determine the exact cause of the reported phenomenon since the information from omsi did not contain detailed information about the subject foreign material.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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