Model Number TJF-160VR |
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 medical systems (b)(4), it was found that there was foreign material on groove or gap of the distal end 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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The subject device was not 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 correct date of "g3: date manufacturer received" is "october 1st, 2021", not "september 30th, 2021" as reported in the initial report.The subject device was returned to olympus medical systems india (omsi).Olympus medical systems corp.(omsc) has obtained the following additional information from olympus medical systems india (omsi): - the subject foreign material had been found on the forceps elevator.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 insufficient cleaning around the forceps elevator 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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