The olympus territory manager reported (on behalf of the customer) that while using the single use injector, fluid was not dispensing through the syringe into the patient as intended.The issue occurred during the therapeutic procedure, and the procedure was completed with a similar device.There was no procedural delay or additional devices associated with the event.There was no patient harm associated with the event.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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, the visual inspection of the used device found no abnormality on the tubing appearance.There were no kinks inside the needle tube, and no crack around the injection port.The slider could extend or retract the needle smoothly.When a test syringe was used to inject water into the injection port, it was confirmed that fluid was not able to expel out when the needle was in the sheath, and when the needle was out of the sheath the water would not flow.No water leaked from the tube sheath during water injection.Further evaluation was performed by opening the handle and found the inner needle tubing of device appeared to be buckled inside the handle.It was determined that liquid could not be injected due to compressive buckling of the needle tube.However, the definitive root cause of the compressive buckling could not be determined.A likely mechanism causing friction resistance between outer tube and needle tube might be either the tube having been coiled during the inspection for operation, or the slider being pushed abruptly.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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.¿ olympus will continue to monitor field performance for this device.
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