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Model Number NM-401L-0623 |
Device Problems
Mechanical Problem (1384); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation result: the model number nm-401l-0623 was received for evaluation.The lot number was 16v with supplementary information number of ¿18¿.(m-bc manufacture date: june 18, 2021).Device evaluation , the following noted : the needle could extend from the outer tube.It was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The outer tube was not buckled.The needle tube presented compressive buckling.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.Ifu (instruction for use) : the instruction manual contains the following descriptions, and it warns against this event.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.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.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.Conclusion : it is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation.Olympus will continue to monitor complaints for this device.
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Event Description
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As reported, a problem has occurred with the sample product (demo product).The doctor inserted it into the forceps channel and tried to inject the drug solution (kenacort) locally, but the injection amount was too heavy to inject.User tried to see if the drug solution came out even outside the body cavity but it did not.The device was replaced.The intended procedure (vocal cord steroid injection (therapeutic) was completed with a similar device.There was no patient harm, no user injury reported due to the event.According to the reporter, the device was inspected prior to use, no problem found during the preoperative injection check.This report is being submitted for injection needle malfunctions, problem of puncture / problems of delivering liquid.Unable to inject liquid.
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Manufacturer Narrative
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This report is being supplemented to provide additional information.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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