Model Number TJF-150 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, 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 olympus (b)(4), it was found that there was the yellow stain and/or dirt inside of the light guide lens of the subject device.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.The subject device in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus india there was the possibility that the reported phenomenon was attributed to the moisture or foreign object invasion into the device from the air leakage part because there was air leakage at the control section.
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Search Alerts/Recalls
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