The subject device was not returned for evaluation.Based on legal manufacturer investigation, it was unable to confirm the event pointed out due to the actual product was not sent for evaluation.Review of the following dhrs (device history records) for the manufacturing lot number of the equipment, showed no abnormalities in the items related to the reported event.Process inspection slip.Quality inspection slip.Non-conforming product parts processing table.From the confirmation result of dhr, it is considered that there is no problem with the product.Therefore, it was judged that it is not necessary to investigate using equipment with the same structure or similar equipment.Review of ifu (instruction for use) the user manual states the following description.Before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, mucous membrane damage may result.If you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result.Conclusion summary: in the manufacturing process of this product, the operation of all needle adjusters were confirmed, therefore it is believe that there was no problem with the operation of the needle adjusters at the time of shipment.It is probable that the reason why the needle could not be fixed was not because of the groove near the scale of the handle, it was due to the needle adjuster was fixed in the convex position, however, the cause could not be identified.Olympus will continue to monitor complaints for this device.
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