Model Number NM-401L-0523 |
Device Problem
Failure to Infuse (2340)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
|
|
Event Description
|
We received the following report.The test with the needle prior to use was flawless.Then after the needle was extended, it was not possible to inject.There was no patient injury reported.This is the report regarding the failure of the injection.
|
|
Manufacturer Narrative
|
This is a supplemental report to provide additional information.Two devices were returned to olympus medical systems corp.(omsc) for evaluation.This is the first one of two reports.When we push the slider, we could not inject a liquid.However, we pulled the slider, we could inject a liquid.The tube had no kink and no deformation.The needle tube of the device had compressive buckling.There was a foreign substance on the tube.The manufacturing record was reviewed and found no irregularities.Aomori olympus concluded that the phenomenon occurred due to the compressive bucking on the needle tube.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 above device handling has warned in the instruction manual.
|
|
Search Alerts/Recalls
|