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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 10/26/2023 |
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 10/26/2023, it was alleged by a facility representative via (b)(4) that an ar-8330h shaver hp hand control was not recognized when plugged in.This was discovered during the case.Another device was used to complete the case with no patient harm.
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Manufacturer Narrative
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Correction, h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
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Search Alerts/Recalls
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