The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle could not be extended from the outer tube.Injection could not be performed while the slider was pushed, but injection could be performed while the slider was pulled.The outer tube was buckled at 280 mm, 395 mm and 560mm from the distal end.The needle tube was compressive buckled.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the frictional resistance between the outer tube and the needle tube increased due to the bending of the tube or pushing the slider fast, and then the needle tube was compressive buckled when the needle was extended and injection could not be performed.The above device handling has warned in the instruction manual as follows.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.When inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.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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During an unspecified procedure, the subject device was used.The needle could not be extended.The intended procedure was completed with another device.There was no patient injury reported.On july 3, 2020, olympus medical systems corp.(omsc) found that the subject device could not perform the injection.This is the report regarding the failure of injection.
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