An olympus representative was informed by the user facility of a report that, upon deployment of the olympus, model nm-401l-0425 single use injector, it failed to dispel fluid; "it got jammed." the problem caused a delay in procedure of a few seconds while a new package was opened; there was no adverse health effect to the patient attributed to the delay.The intended procedure is unknown but it was reported that it was likely a "botox" procedure.The intended procedure was completed with another needle.There was no patient injury, associated with the problem, reported to olympus.This is report #1 of 2 due to multiple devices reported.
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This supplemental report is being submitted to provide additional information based on the evaluation results on the returned device, and legal manufacturer¿s investigation.In addition, this report is being submitted to correct the following sections: d4, d9, g3, h2, h3, h6, and h10.The customer returned the injector needle, model nm-401l-0425 with the with lot number k8y15 for evaluation.The injector (subject device) was received with needle retracted inside, and intact.There is no biomaterial inside the tubing, but the outer tube sheath was kinked at the handle boot.The handle appeared to be normal, but the slider could not push the needle out from the distal end.The needle got jammed inside.When using a test syringe to inject water into the injection port, fluid was able to expel out when the needle was inside the tube sheath.No water leakage found from the tube sheath during the water injection.Further troubleshooting, the slider was disassembled, and found the needle tube to be kinked about 15mm long from the slider distal rod.Based on the evaluation findings, the reported complaint was confirmed.The deep kinks on the outer sheath and on the needle tube could have contributed to the reported complaint.The legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.There were no abnormalities detected in the dhr for the following items, which is related to the reported phenomenon: needle extension and retraction, extended length of needle, no bent/kink/crack/scratch on the tube, and injection of the liquid.The device instruction manual contains the following descriptions, and it warns against this reported event ((b)(4)): ¿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 the biopsy valve, and keep it as straight as possible relative to biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope 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.¿ a review of similar reported complaint in the past, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped, as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore, 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.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The kink of the tube.Angle of the distal end of the endoscope.Although, the subject device was not returned the factory for evaluation, it is possible to infer that the cause of the previous complaint is also similar based on the investigation conducted by the legal manufacturer.
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