The subject device was returned to olympus medical systems corp.(omsc) for evaluation.When we push the slider, we could not inject a liquid.However, we pulled the slider, we could inject a liquid.The tube had no kink and no deformation.The needle tube of the device had compressive buckling.There was a foreign substance on the tube.The manufacturing record was reviewed and found no irregularities.(b)(4) olympus concluded that the phenomenon occurred due to the compressive bucking on the needle tube.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The above device handling has warned in the instruction manual as follows.Operate the slider slowly, otherwise the tube could buckle.Stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.
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We received the following report.The test with the needle prior to use was flawless.Then after the needle was extended, it was not possible to inject.There was no patient injury reported.Two devices were returned to olympus medical systems corp.(omsc) for evaluation.On july 3, 2020, omsc found that the second device was not possible to inject under some condition.This is the report regarding the failure of the injection.This is the second one of two reports.
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