Model Number NA-U401SX-4021 |
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 endobronchial ultrasound-guided transbronchial needle aspiration, the subject device was used.When the endoscope was angled, the needle tube of the subject device was protruded about 15 mm from the distal end of the endoscope despite the correct adjustment of the needle tube.It was reported that the patient's lung mucosa might suffer lesions, but no additional treatment was performed in the case.It was also reported that several patients were affected, but the exact number of patients is unknown at this time.This is the report regarding the inability to fix the needle tube.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.The needle adjuster lever was not fixed in the right position.The needle adjuster moved to the release direction when operating the needle.The needle adjuster was unlocked.The needle protruded longer than needed.The above device handling has warned in the instruction manual.
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Search Alerts/Recalls
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