Model Number TJF-Q180V |
Device Problems
Material Discolored (1170); 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 10/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Since the subject device has been not returned to omsc for the 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 from the user that it was found the dirt inside the light guide lens of the subject device at the unspecified timing.At the incoming inspection for the repair, olympus india found that the stain entered inside the light guide lens of the subject device.There was no patient injury associated with this report.
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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.The exact cause of the reported phenomenon could not be conclusively determined.However, 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 peeled adhesive around the light guide lens, because damage (scratch, dent) has been confirmed at the distal end.
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Search Alerts/Recalls
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