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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 stalling has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr 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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Event Description
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In this event it was reported that a vdw.Silver reciproc stops during treatment.No patient injury.
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Manufacturer Narrative
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Battery (voltage breaks down under load) defective, replaced.Foot control (b)(6), micromotor (b)(6) and contra-angle handpiece (b)(6) (2012) are not defective.Function test without errors.
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Search Alerts/Recalls
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