Model Number OTV-S7H-D-L08E |
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 Type
malfunction
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Manufacturer Narrative
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The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, 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 service operation repair center, the device had poor water tightness and foreign matter adhering to the leaking part.Other detailed information was not provided.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.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the device was not returned, the exact cause was unknown.However there was the possibility that the reported phenomenon was attributed to the insufficient reprocessing of the device by the user.The instruction manual of the device states the corresponding method in case of an abnormality.
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Search Alerts/Recalls
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