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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Output Problem (3005)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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While no serious injury resulted in this event, calibration related issues in endo motors have led to file separation in the past.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 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 was reported that a vdw.Silver reciproc stops during treatment; no injury resulted.
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Manufacturer Narrative
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Motor cable (cable break) defective, replaced.Battery (voltage breaks down under load) defective, replaced.(b)(6) (broken cable) defective, replaced with (b)(6).Display pane defective, replaced.(b)(6) checked.The housing has cracked in several places (presumably due to an impact) has no effect on the function.Without contra angle function test without errors.
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Search Alerts/Recalls
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