Model Number TJF-Q180V |
Device Problems
Break (1069); 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 10/31/2020 |
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 the service department of olympus (b)(4), it was found that there was a gap of adhesive on the distal end and/or the stain had entered inside the lens through the gap.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 stain invasion into the device from the peeled adhesive around the light guide lens.The exact cause of the peeling of adhesive could not be conclusively determined.However, there was the possibility that the peeling was attributed to the external stress such as hitting the distal end against an object, or the chemical stress of reprocessing, or storage environment.
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Search Alerts/Recalls
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