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Model Number SHVR HP,SYNERGY,HANDCNTRL,BACKHAND |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
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 12/19/2023, it was reported by a sales representative via sems-06435320 that an ar-8332rh shaver hand piece is wobbly.This was discovered during a procedure with no patient harm.Another device was swapped to complete the case.
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Manufacturer Narrative
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(no problem found) the evaluation did not reveal any issues relevant to the reported event, "on 12/19/2023, it was reported by a sales representative via (b)(4) that an ar-8332rh shaver hand piece is wobbly.This was discovered during a procedure with no patient harm.Another device was swapped to complete the case.".
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Search Alerts/Recalls
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