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Catalog Number V041441000000 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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In this event it is reported that eddy irrigation tip broke during use.No injury occurred.
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Manufacturer Narrative
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While no serious injury resulted in this event, 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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Manufacturer Narrative
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Investigation: 04.08.2023 sg vdw: investigation done: no smooth breakage, breakage do to thermal influence.Misuse nothing unusual to report was found during dhr review.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Root cause: customer misuse/abuse; conclusion code: user error.
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Search Alerts/Recalls
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