The device was returned to olympus for evaluation and the customer's allegation of ¿reduced angulation¿ was confirmed.The device evaluation found due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to wear of the angle wire, the play of up/down knob was out of the standard value.Additionally, there was foreign matter on distal end cover, the forceps elevator, and debris clogged the nozzle due to insufficient cleaning.And the plastic distal end cover had a dent.The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure what the foreign material adhered to the scope was.Additionally, it was confirmed there was no delay in the start of pre-cleaning, the customer flushed the nozzle with water and air.They did not confirm if there were no abnormalities in the accessories used for reprocessing.They did not confirm whether they¿ve presoaked the endoscope in detergent solution, they did not wipe the nozzle with clean lint-free cloths/brushes/sponges, and they flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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