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Model Number NM-401L-0425 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has been returned to olympus for evaluation.Visual inspection was performed on the device and found no abnormality on the tubing appearance.Observed no kinks inside the needle tube, and no crack around the injection port.The slider could extend or retract the needle smoothly.Further checking, when using a test syringe to inject water into the injection port, confirmed that fluid was able to expel out when the needle was in the sheath, but when the needle was out of the sheath, the fluid would not flow.No water leak was that from the tube sheath during water injection.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.Product return receipt date is not available currently.
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Event Description
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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.This report is part of three related events.(patient identifiers: (b)(6) and (b)(6).
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Manufacturer Narrative
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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, the inner needle tubing of the device appeared to be buckled inside of the handle.However, the definitive root cause of the needle issue could not be determined.It is possible that the compressive bucking occurred due to increased friction resistance between the outer tube and the needle tube when the needle was extended.Friction resistance between the outer tube and the needle tube may have been caused by the tube being 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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Search Alerts/Recalls
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