Model Number G31520 |
Device Problems
Break (1069); Material Deformation (2976)
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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 07/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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510(k) number: k083330.(b)(4).(b)(6).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 user opened the package and check the integrity of the device and found out the tip of the sheath broken.
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Manufacturer Narrative
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510 (k) number: k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(6).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial report submitted.Initially this report was conservatively assessed as a proximal sheath kink that has a risk associated with it that is not remote.Upon receipt of the device the sheath was damaged distally and no kink was confirmed therefore the updated failure mode assigned is categorized as low risk and therefore no longer meets the fda malfunction reporting criteria.No precedence exists for this event and no patient injury occurred.
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Event Description
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This follow up report is being submitted to cancel the initial report submitted.Initially this report was conservatively assessed as a proximal sheath kink that has a risk associated with it that is not remote.Upon receipt of the device the sheath was damaged distally and no kink was confirmed therefore the updated failure mode assigned is categorized as low risk and therefore no longer meets the fda malfunction reporting criteria.No precedence exists for this event and no patient injury occurred.
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Search Alerts/Recalls
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