Model Number GF-UCT260 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The 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 service operation repair center was informed that during preparation for use, it was found that the foreign matter adhering to around forceps elevator of the device (olympus loaner).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.The device was returned to olympus service operation repair center (sorc).Sorc checked the device and found that there was the foreign matter and the dirt of the distal endo of the device.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.Based upon the information from sorc, there was the possibility that the reported phenomenon was attributed to the insufficient reprocessing of the device by the user.
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Search Alerts/Recalls
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