Device evaluated by manufacturer: the device was returned for analysis.The actual item was returned in its unopened packaging.From visual inspection of the sterilization bag, it was confirmed that oil had adhered to the film part of the sterilization bag.Oil adhering to the inside of the film of the sterilization bag were investigated by fourier transform infrared spectroscopy (ft-ir) test, and it was confirmed that this oil was silicone oil applied to the hemostatic valve of the sheath.From inspection of the area around the sheath including the hemostatic valve, it was confirmed that silicone oil had adhered.Process of applying silicone oil to the hemostasis valve of the sheath was investigated, and it was confirmed that the silicone oil which was excessively put on the hemostasis valve was wiped off.
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