Model Number NA-201SX-4022 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) 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.
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Event Description
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During an unspecified procedure, the subject device was used.The needle adjuster lever could not be locked.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the inability to fix the needle adjuster lever.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.When the needle adjuster level was slid, the needle tube could be fixed and released although there was resistance.The convex part of the needle adjuster lever was deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it is presumed that the needle tube could not be locked since the needle adjuster lever was slid not to the groove near the scale on the handle but to the convex part, and then the convex part of the needle adjuster was deformed and not fixed to the right position.
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Search Alerts/Recalls
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