Model Number OER-4 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/30/2020 |
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 a reprocessing, the detergent replacement indicator of the subject device did not go out.The field service engineer visited the user facility, replaced the sensor of the subject device and the issue was resolved.No error had occurred.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 not returned to the 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, there was the possibility that the reported phenomenon was attributed to the following.The subject device was used after long-term storage without use.The detergent residue had adhered to the detergent sensor or the detergent tube.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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