Model Number NM-401L-0623 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, the customer have experienced 3 (three) injector force max model no.Nm-401l-0623 needle failures.The same scenario, when the needle is extended outside the shaft unable to inject the fluid.The initial prime of the needle is fine.The issue occurred during an unspecified procedure.The customer stated the first 3 needles that was used had the same issue and did not worked.The fourth needle from the same box worked as expected and the intended procedure was completed with no harm or injury to the patient.There was no user injury reported.Customer did not provide the lot number of the needle used to complete the procedure.This report is related to reports with patient identifier (b)(6).
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on customer follow up and updates.Further communication with the customer conveyed the following information: customer stated that there are 2 needles failed on (b)(6) 2021.The two needles were used in one case, same patient.The 2 needles failed and the 3rd one used completed the procedure.No patient injury, no user injury.Customer stated that the 2 needles used on the same procedure are being returned however, a third needle is also being returned and was not used.Customer stated that they do not trust the needle so it will be returned.She will return total of 3 needles.To date the subject device has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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Updates on event reported.Two needles failed during the procedure.The third needle was used to complete the case.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Device evaluation confirmed the customer's complaint.A visual inspection on the received condition and noted white foreign residue lodged inside the insertion portion tube.The white residue inside of the tube is in various sections throughout.Upon testing the actual device, white foreign residue began to expel out the distal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, the compressive buckling on the needle tube was likely caused when the needle was extended because of 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 the specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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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