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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 03/06/2024 |
Event Type
malfunction
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Event Description
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On 03/06/2024, it was reported by a facility representative via (b)(4) that an ar-8330h shaver handpiece's attachments were not functioning correctly.This was discovered during a 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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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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 03/06/2024, it was reported by a facility representative via (b)(4) that an ar-8330h shaver handpiece's attachments were not functioning correctly.This was discovered during a procedure with no patient harm.".
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Search Alerts/Recalls
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