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Model Number NM-401L-0423 |
Device Problems
Mechanical Problem (1384); Failure to Infuse (2340); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address-full address name of the facility - (b)(6).The subject device was received and evaluated.Device evaluation found the tube was kinked.Device evaluation noted, needle able to be retracted (able to inject)- able to inject fluid in retract position.Device evaluation noted, needle able to be extend (unable to inject)- needle can be extended however, cannot inject fluid.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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It was reported at preparation for use (before procedure) for a therapeutic gastric ulcer (bleeding case), the nurse inspected, tested the injector and found no problem.However, during the procedure, when the injector (with needle out) was inside the scope, the nurse injected the adrenaline solution and was able to flow.However, for the second time, when the injector (with needle out) was inside the scope, the nurse injected adrenaline solution and the solution got stuck and cannot flow through the lumen despite trying for many times.The nurse tried to examine and test the injector after taking it out from the scope, however, the same issue transpired.A second injector (similar device) was opened to continue the procedure, however, the second injector had the same issue.The intended procedure however, was completed using the second injector and with no harm reported.The patient was reported to be in good status.No patient harm, no user injury reported due to the event.This event includes two (2 ) reports: report with patient identifier (b)(6) (first injector) report with patient identifier (b)(6) (second injector) this report being submitted is for report with patient identifier (b)(6) (first injector).
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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.Section d4 was corrected with information that was inadvertently omitted from the initial report.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 definitive root cause of the kinked tube sheath could not be determined.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.The friction between the outer tube and the needle may have increased due to the needle having been extended or retracted while the tube was coiled in inspection of operation, the slider being abruptly pushed, the angle of the endoscope¿s distal end, or the tube kink.A bending force might have been applied to the tube when the device was withdrawn from the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Use care when operating the nm-401 series.Otherwise, the insertion portion could be damaged.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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Search Alerts/Recalls
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