Catalog Number V041079000000 |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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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 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that wst 6:1 f.Vdw.Gold/silver was returned with a broken file inside.No information regarding injury or information received.Requested further information.
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Manufacturer Narrative
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Contra-angle 110946(2017) (broken file in the head) defective, repaired.Functional testing without errors.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
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Search Alerts/Recalls
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