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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Energy Output Problem (1431)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Even if 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 is reported that vdw silver reciproc device having speed issue during use, speed of device is inconsistent.Outcome of injury is unknown as of this mdr and is pending.
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Manufacturer Narrative
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Battery (voltage collapses under load) defective, replaced.The housing was broken (probably due to a fall) and had an impact on the function (defective).When the housing was renewed, the display pane and the membrane keyboard were also replaced.Micromotor smr 118616, contra-angle 138004 (2019) and foot control 190417 checked, without errors.Sent without power supply.Function test without error.
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Search Alerts/Recalls
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