Model Number TJF-150 |
Device Problems
Device Reprocessing Problem (1091); 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 the reported phenomenon, and also surmised that this phenomenon was attributed to insufficient cleaning by the user.In addition, there was a possibility that the subject device was used to the patient with the foreign material attached.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 for repair of the subject device at olympus (b)(4), it was found that there was foreign material on the forceps elevator of the subject device.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).Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from omsi and similar past cases, omsc surmised that this phenomenon was attributed to inappropriate reprocessing by the user.The instruction manual of the subject device states appropriate reprocessing method.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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