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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
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 burr continues spinning.This was discovered during a procedure with no patient harm.
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Manufacturer Narrative
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Additional information: d9, g3, h6.(no problem found) the evaluation did not reveal any issues relevant to the reported event, "on (b)(6) 2023, it was reported by a sales representative via sems that an ar-8330h shaver burr continues spinning.This was discovered during a procedure with no patient harm.".
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Search Alerts/Recalls
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