Catalog Number V041079000000 |
Device Problems
Fitting Problem (2183); Detachment of Device or Device Component (2907)
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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 a wst 6:1 f.Vdw.Gold/silver won't hold files.No injury occurred.Device will be returned for investigation.
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Manufacturer Narrative
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There has been a previous report received with a similar device 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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(b)(4)/ sn:(b)(6):after a thorough check and test measurements by two technicians, we could not find any errors.Please note the information in the operating instructions.Contra angel (b)(4) (2021) cleaned and oiled.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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