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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problems
Device Alarm System (1012); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
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-8330h shaver handpiece had an h15 error.This was discovered at the beginning of the case, with no impact on the patient.This occurred during use with no patient harm.Additional information has been requested.
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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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Additional information: (motor) the evaluation confirmed the reported event, "ar-8330h shaver handpiece had an h15 error.This was discovered at the beginning of the case, with no impact on the patient."; and attributed to motor hall sensor malfunction.(refer to ncr-22401).
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Search Alerts/Recalls
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