Catalog Number A066100000200 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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In this event it is reported that start-x tip ems insert 2 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
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Manufacturer Narrative
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There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
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Manufacturer Narrative
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Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1651405).No information was given regarding technique, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.
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Search Alerts/Recalls
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