This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. it was confirmed that there was dirt on the light guide lens glue and the light guide lens, which might indicate the insufficient reprocessing.Therefore the causes were presumed as below: - there was the possibility that the brushing method for the forceps elevator by the user differed from the brushing method for the forceps elevator recommended in the instruction manual.- there was the possibility that the trainings for the facility staff that the device handling according to the instruction manual, the reprocessing when the device was returned after repair and/or the general reprocessing, were insufficient. there was the dent on the distal end of the subject device.Therefore the causes were presumed as below: - there was the possibility that physical stress made gap at the light guide lens glue, and dirt entered from the gap.- there was the possibility that the components inside the light guide lens were corroded due to the moisture ingress into the subject device, consequently corrosion product was left as dirt.If additional information becomes available, this report will be supplemented.
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