COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL
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Model Number G48026 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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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 08/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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510(k) number: k163468.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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As reported to customer relations: "during deployment, on the second trigger squeeze they heard a click and continued to try to deploy.However, with each trigger squeeze they were unable to deploy (no resistance, but no action).Removed stent and delivery system.No harm to patient.Nothing left behind in the patient.Another of the same gpn was used to complete the procedure.
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Manufacturer Narrative
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510(k) number: k163468 this report is being submitted as a cancellation report.From the initial information received, this event was cautiously made reportable based on the precedence in place for this device of 'flexor kinked/stretched/broken/compressed'.However, when the returned device was received it was confirmed during the lab evaluation that this malfunction did not occur.The following failure has been confirmed: "shuttle assembly does not remain intact, stent cannot be deployed.Replacement device required".Overall risk assessed as category iii (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
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Event Description
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As reported to customer relations: "during deployment, on the second trigger squeeze they heard a click and continued to try to deploy.However, with each trigger squeeze they were unable to deploy (no resistance, but no action).Removed stent and delivery system.No harm to patient.Nothing left behind in the patient.Another of the same gpn was used to complete the procedure.
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Search Alerts/Recalls
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