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 returned to (b)(4).(b)(4) checked the subject device and found that the reported phenomenon was caused by insufficient cleaning.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 there was foreign material on groove or gap of the distal end.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 presumed that the reported phenomenon was attributed to the following.After the procedure the reprocessing around the forceps elevator by the user was insufficient.The user did not reprocess the subject device immediately after the procedure, then the foreign material on the forceps elevator got dry and remained.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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