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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problems
Application Program Problem: Power Calculation Error (1473); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8330h shaver has an h15 error.This was discovered during a case with no patient effect.
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Manufacturer Narrative
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(motor) the evaluation confirmed the reported event, "ar-8330h shaver has an h15 error.This was discovered during a case with no patient effect."; and attributed it to a motor hall sensor malfunction.(refer to ncr-22401).
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Search Alerts/Recalls
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