This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since the device was not returned the exact cause could not be determined.However, a similar complaint reporting ¿unable to inject liquid into the target tissue,¿ occurred due to the compressive bucking on the needle tube.It is unlikely that a device with a defective needle was shipped, as the device undergoes full inspection for appearance, needle operation and injection.Therefore, the compressive buckling on the needle tube was likely caused when the needle was extended due to great friction between the outer tube and the needle.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿the operator of this instrument must be physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual does not explain or discuss clinical endoscopic procedures.¿ ¿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.¿ olympus will continue to monitor field performance for this device.
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