Model Number TJF-Q180V |
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 that the reported phenomenon was 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 that during the incoming inspection for repair at the service department of (b)(4), it was found that there was a foreign material on groove or gap of the distal end.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, it is presumed that the suggested event occurred by the following user handling.-user conducted insufficient reprocessing around forceps elevator after procedure.-foreign material on forceps elevator got dry and adhered since the user did not reprocess device immediately after procedure.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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