The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.When omsc checked the use log of the subject device, there was no error about the concentration of the disinfectant solution.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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The user alleged that disinfectant solution used for this device got expired too soon.The user tested the concentration level of the disinfectant solution before running the device's reprocessing cycle and and confirmed that it had an effective value.After three reprocessing cycles, the user tested the concentration level again and the test results indicated it was expired.The customer was concerned about a possibility that scopes might have not been reprocessed properly.There was no patient injury report related to the event, including infections.
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