The subject device was returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc performed analysis of component of the white crystalline material, oxygen, carbon and silicon were detected mainly.Therefore the it was considered that the white crystalline material was mixture of the peracetic acid (disinfectant solution) and some kind of silicone-based material which might be antifoam agent or other medical agent.It was considered that there was the possibility that these might be mixed into the reprocessing basin, or these could not be rinsed completely then remained in the reprocessing basin.However the exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.
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