Model Number G34279 |
Device Problems
Break (1069); Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The 510k) number: k160229.(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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Needle broke into pieces when pulling back from the endoscope."as per complaint form": the needle broke into pieces when the physician the needle pull back from the endoscope.
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Manufacturer Narrative
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510k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial mdr report.A conservative assessment deemed this event reportable based on the assumption that surgical intervention was required to retrieve the broken needle.However, following the device evaluation the needle was fully intact and a proximal needle kink was present.Overall risk assessed as category iia (low).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 report is being submitted to cancel the initial mdr report.Needle broke into pieces when pulling back from the endoscope."as per complaint form": the needle broke into pieces when the physician the needle pull back from the endoscope.
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Search Alerts/Recalls
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