From (b)(6) 2020, the user facility introduced and started using the olympus endoscope reprocessor (oer-4; 1 unit, oer-5; 2 units).From (b)(6), the three reprocess staffs and one physician worked on the week day at the facility and they pleaded headache after returning home every day.They recovered at the weekend.They did not get medical attention.No error had occurred in the subject devices.They wore surgical masks before (b)(6), but after (b)(6) they switched to n-95 masks and no longer felt headaches.The user facility did not provide other detailed information.According to the number of patients and the number of olympus devices, olympus medical systems corp.(omsc) is submitting 12 medical device reports.This is 7 of 12 reports.
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This supplemental report is being submitted to provide additional information.The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.A causal relationship between the reported headache and 6% acecide disinfectant could not be excluded.As described in "ensuring the safety of reprocessing personnel" in the operation manual for oer-4 and oer-5, the disinfectant vapor generated by this device has been proven safe in in-house testing.Nevertheless, as individual reactions to the disinfectant may vary, olympus recommends the use of gas filters and enhanced protection by observing the ventilation conditions given in "ensuring the safety of reprocessing personnel".If additional information becomes available, this report will be supplemented.
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