It was reported that the olympus injection needle experienced an injection failure during multiple cases.Reportedly, the nurse had primed the needle prior to use without issue.However, after inserting the needle into the scope, it deployed, but no solution was injected due to a blockage.The issue occurred during a diagnostic bronchoscopy procedure.The procedure was completed using the subject devices with no reports of patient harm.
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This supplemental report is being submitted to provide a correction, the results of the device evaluation and the results of the legal manufacturer's final investigation.Correction added to field: d4: (lot).A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The device was returned to olympus for inspection.And the reportable malfunction was confirmed.Based on the results of the investigation, it is likely, the reported event occurred, due to compressive bucking on the needle tube.The compression was likely, caused when the needle was extended, due to great friction between the outer tube and the needle.The friction between the outer tube and the needle likely increased, due the following factors: the needle extended/retracted, while the tube was coiled in inspection of operation.The slider was abruptly pushed.Angle of the distal end of the endoscope.The tube was kinked additionally, a bending force may have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.However, a root cause could not be determined.The event can be detected/prevented, by following the instructions for use, which state: 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.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.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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