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Model Number SHAVER HP, SYNERGY, HANDCONTROL |
Device Problems
Defective Component (2292); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2023 |
Event Type
malfunction
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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-8332h shaver hp had a h15 shaver failure.This was discovered during an unspecified procedure, with no patient harm.
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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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Manufacturer Narrative
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(motor) the evaluation confirmed the reported event, "ar-8332h shaver hp had a h15 shaver failure.This was discovered during an unspecified procedure, with no patient harm.", and attributed it to a motor hall sensor malfunction.(refer to ncr-22401).
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Search Alerts/Recalls
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