DENTSPLY VDW GMBH VDW GOLD/SILVER CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
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Catalog Number V041079000000 |
Device Problems
Mechanical Problem (1384); Output Problem (3005); Noise, Audible (3273)
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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 this malfunction 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 contra angle 6:1 for vdw.Gold/silver stops during treatment.It also makes unusual noises.No patient injury occured.
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Manufacturer Narrative
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Contra-angle handpiece 131133 (head drive) defective, replaced by contra-angle handpiece 128836 (2018).
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Search Alerts/Recalls
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