Model Number G34785 |
Device Problems
Bent (1059); Kinked (1339); No Apparent Adverse Event (3189)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The 510(k) number: k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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The device was used for eus-fna.The first device ((b)(4)): the needle was advanced from the duodenum bulb to the pancreas head.At the second attempt of biopsy, the distal luer lock could not be attached to fujifilm's endoscope properly.Therefore, the device was replaced with another echo-hd-3-20-c.The second device ((b)(4)): biopsy was continued with the second device though, the distal luer lock could not be attached to the endoscope properly.Therefore, olympus's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.
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Manufacturer Narrative
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510(k) number: k142688.(b)(4).Exemption number: e2016031.(b)(4) this follow up mdr is being submitted to cancel the initial mdr report.A conservative approach was taken in initially assessing the lab evaluation.After further review of the lab evaluation it can be confirmed that the needle did not kink distally.The bend at the distal end of the needle is contributed to natural procedural curvature.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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This follow up mdr is being submitted to cancel the initial mdr report.A conservative assessment deemed this event reportable based on the needle kinking distally.However, following device evaluation the bend noted on the device is a natural procedure curvature and not a kink.
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Search Alerts/Recalls
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