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Catalog Number V041163000000 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384)
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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 silver reciproc motor is loosing contact and spins without any control; no injury resulted.
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Manufacturer Narrative
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Battery (voltage breakdown) defective, replaced.Motorholder (broken) defective, replaced.Micromotor smr1455304, contra angle 73083 (2014) and foot control 102962 are not defective.Functional test without error.
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Search Alerts/Recalls
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