Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, it was found the following.- during the reprocessing with the subject device, the error e16 which indicated that it takes too long to fill the reprocessing basin with disinfectant solution occurred.The user checked the subject device and found the foreign material (pieces of rubber) in the reprocessing basin.There was the possibility that the filter of the circulation port might be clogged by the foreign material and the error e16 might occur.There was no report of patient injury associated with the event.
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This supplemental report is being submitted to provide additional information.The subject device was not returned to omsc for evaluation, but the foreign material was returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc checked the subject foreign material was and found that the returned foreign material was a black, elastic substance.As a result of performing an organic qualitative analysis on the foreign material for the substance investigation, it was found that the waveform of the foreign material was equivalent to that of the pipeline hose of the subject device.From this result, color and characteristics, omsc considered that the foreign material was a substance similar to the pipeline hose of the subject device.Omsc surmised that there was the possibility that a part of the wetted surface of one of the pipeline hoses deteriorated and peeled off and it was washed away as the foreign material.Subsequently there was the possibility that when the disinfectant was collected, the foreign material was moved to the disinfectant tank.If additional information becomes available, this report will be supplemented.
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